MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2017-05-02 for IMPRA EPTFE VASCULAR GRAFT 40S06 manufactured by Bard Peripheral Vascular, Inc..
[74252404]
No medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. Clinical trial results review: the subject had a study conduit successfully placed in the right upper arm. Approximately forty-seven days post conduit implant, the subject had previously undergone four sessions of dialysis through the pre-existing line and the subject experienced thrombosis of the vascular access that was severe in intensity. Approximately fifty-three days post conduit implant, the subject underwent a successful thrombectomy procedure and was hospitalized overnight for observation. The subject was discharged from the hospital the following day with resolution of the thrombosis of vascular access. Approximately fifty-nine days post conduit implant, the subject restarted using the conduit for dialysis. No further complications were noted. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[74252405]
It was reported through the results of a clinical trial, approximately forty-seven days post conduit implant the subject experienced thrombosis of the vascular access that was severe in intensity. Approximately six days later, the subject underwent a successful thrombectomy procedure and was hospitalized overnight for observation and was discharged home the following day. Approximately six days post thrombectomy, the subjected restarted using the conduit for dialysis. No further complications were noted.
Patient Sequence No: 1, Text Type: D, B5
[86899438]
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: as medical records were not provided, a review could not be performed. Clinical trial results review: the subject had a study conduit placed in the right upper arm. Approximately forty days post conduit implant, the subject underwent the first cannulation of the conduit for dialysis use. Approximately forty-seven days post conduit implant, the subject experienced a thrombosis of the vascular access that was severe in intensity. Prior to dialysis, an assessment of the conduit revealed no sign of infection at the site; however, thrill and bruit were not noted. An attempt was made to needle the conduit; however, only blood clots were noted and a thrombectomy was planned. Approximately fifty days post conduit implant, the subject was dialyzed vie the pre-existing tunneled graft. Approximately fifty-two days post conduit implant, the subject was again dialyzed via the pre-existing tunneled graft. The subject was discharged in stable condition with a thrombectomy planned for the following day. Approximately fifty-three days post conduit implant, the subject underwent a successful thrombectomy of the right arm av graft. Under ultrasound guidance, a patent segment of the study conduit was accessed and a wire and sheath were easily advanced. Using an angiojet catheter, the thrombus was laced with approximately 15 mg of tissue plasminogen activator (tpa). Two passes of the catheter were made and digital subtraction angiography demonstrated the conduit to be patent, but with a long segment or irregular stenosis involving the venous anastomosis and the juxta-anastomotic outflow vein. Angioplasty was performed with overlapping inflations and good results were noted. Completion venography confirmed no central vein stenosis. The sheath was removed, manual compression was held for 10 minutes, and two sutures were placed to secure hemostasis and a dressing was applied. No immediate complications were noted and there were no post-procedural complaints of pain. A study conduit thrill and bruit were present. Removal of the sutures and hemodialysis were scheduled for the following day. The subject was admitted overnight for observation with plans to discharge the next day. Approximately fifty-four days post conduit implant, the subject was discharged from the hospital with the thrombosis of vascular access reported as resolved. Approximately fifty-nine days post conduit implant, the subject started reusing the conduit for dialysis. No further complications were noted. Image/photo review: as medical images were not provided, a review could not be performed. Conclusion: the device was not returned for evaluation. Medical records and images were not provided for review. Therefore, the investigation is inconclusive for the alleged occlusion within the graft as no objective evidence has been provided to confirm any alleged deficiency with the product. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: adverse reactions potential complications which may occur with any surgical procedure involving a vascular prosthesis include, but are not limited to: disruption or tearing of the suture line, graft, and/or host vessel; suture hole bleeding; graft redundancy; thrombosis, embolic events, occlusion or stenosis; ultrafiltration; seroma formation; swelling of the implanted limb; formation of hematoma or pseudoaneurysm; infection; aneurysm/dilation; blood leakage; hemorrhage; steal syndrome; and/or skin erosion. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[86899439]
It was reported through the results of a clinical trial, approximately forty-seven days post conduit implant the subject experienced thrombosis of the vascular access that was severe in intensity. Approximately six days later, the subject underwent a successful thrombectomy procedure and was hospitalized overnight for observation and was discharged home the following day. Approximately six days post thrombectomy, the subjected restarted using the conduit for dialysis. No further complications were noted.
Patient Sequence No: 1, Text Type: D, B5
[109171584]
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: as medical records were not provided, a review could not be performed. Clinical trial results review: the subject had a study conduit placed in the right upper arm. Approximately forty days post conduit implant, the subject underwent the first cannulation of the conduit for dialysis use. Approximately forty-seven days post conduit implant, the subject experienced a thrombosis of the vascular access that was severe in intensity. Prior to dialysis, an assessment of the conduit revealed no sign of infection at the site; however, thrill and bruit were not noted. An attempt was made to needle the conduit; however, only blood clots were noted and a thrombectomy was planned. Approximately fifty days post conduit implant, the subject was dialyzed vie the pre-existing tunneled graft. Approximately fifty-two days post conduit implant, the subject was again dialyzed via the pre-existing tunneled graft. The subject was discharged in stable condition with a thrombectomy planned for the following day. Approximately fifty-three days post conduit implant, the subject underwent a successful thrombectomy of the right arm av graft. Under ultrasound guidance, a patent segment of the study conduit was accessed and a wire and sheath were easily advanced. Using an angiojet catheter, the thrombus was laced with approximately 15 mg of tissue plasminogen activator (tpa). Two passes of the catheter were made and digital subtraction angiography demonstrated the conduit to be patent, but with a long segment or irregular stenosis involving the venous anastomosis and the juxta-anastomotic outflow vein. Angioplasty was performed with overlapping inflations and good results were noted. Completion venography confirmed no central vein stenosis. The sheath was removed, manual compression was held for 10 minutes, and two sutures were placed to secure hemostasis and a dressing was applied. No immediate complications were noted and there were no post-procedural complaints of pain. A study conduit thrill and bruit were present. Removal of the sutures and hemodialysis were scheduled for the following day. The subject was admitted overnight for observation with plans to discharge the next day. Approximately fifty-four days post conduit implant, the subject was discharged from the hospital with the thrombosis of vascular access reported as resolved. Approximately fifty-nine days post conduit implant, the subject started reusing the conduit for dialysis. Approximately 136 days post conduit implant, the subject experienced thrombosis of the vascular access that was severe in intensity. Approximately three days later, the subject was admitted to the hospital for planned thrombectomy. Approximately 140 days post conduit implant, the subject underwent percutaneous thrombectomy. A mechanical thrombectomy device was utilized to administer the thrombolytic agent in a pulse-spray technique along the thrombosed conduit. After fifteen minutes, the thrombus was aspirated. The distal end of the venous anastomosis of the conduit was angioplastied. After completion of angioplasty, there was local extravasation close to the distal venous anastomosis. A low-pressure balloon was inflated for five minutes, and no extravasation was noted after balloon tamponade. All devices were removed and purse string sutures were utilized to complete the procedure. No immediate complications were noted post-procedure. The subject was discharged from the hospital approximately two days post admission. Approximately 142 days post conduit implant, dialysis utilizing the conduit was attempted; however, unspecified problems were encountered and the subject? S alternate dialysis line was utilized. The subject was awaiting additional surgical review. Image/photo review: as medical images were not provided, a review could not be performed. Conclusion: the device was not returned for evaluation. Medical records and images were not provided for review. Therefore, the investigation is inconclusive for the alleged occlusion within the graft and leak as no objective evidence has been provided to confirm any alleged deficiency with the product. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: precautions: when suturing, avoid excessive tension on the suture line, inappropriate suture spacing and bites, and gaps between the graft and host vessel. Failure to follow correct suturing techniques may result in suture hole elongation, suture pull-out, anastomotic bleeding and/or disruption. Adverse reactions potential complications which may occur with any surgical procedure involving a vascular prosthesis include, but are not limited to: disruption or tearing of the suture line, graft, and/or host vessel; suture hole bleeding; graft redundancy; thrombosis, embolic events, occlusion or stenosis; ultrafiltration; seroma formation; swelling of the implanted limb; formation of hematoma or pseudoaneurysm; infection; aneurysm/dilation; blood leakage; hemorrhage; steal syndrome; and/or skin erosion. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[109171585]
It was reported through the results of a clinical trial, approximately forty-seven days post conduit implant the subject experienced thrombosis of the vascular access that was severe in intensity. Approximately six days later, the subject underwent a successful thrombectomy procedure and was hospitalized overnight for observation and was discharged home the following day. Approximately six days post thrombectomy, the subjected restarted using the conduit for dialysis. No further complications were noted. New information received: it was reported approximately 136 days post conduit implant, the subject experienced thrombosis of vascular accessed that was severe in intensity. After admission to the hospital, the conduit was accessed and a mechanical thrombectomy device was utilized to administer the thrombolytic agent and the thrombus was aspirated. The distal end of the venous anastomosis of the conduit was angioplastied, and upon completion, local extravasation close to the distal venous anastomosis was identified. Balloon tamponade was performed and no extravasation was noted. The procedure was concluded and no immediate complications were noted post-procedure. Approximately 142 days post conduit implant, dialysis utilizing the conduit was attempted; however, unspecified problems were encountered and an alternate dialysis line was utilized. The subject was awaiting additional surgical review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2017-00401 |
| MDR Report Key | 6539280 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2017-05-02 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-03-11 |
| Date Mfgr Received | 2017-08-03 |
| Date Added to Maude | 2017-05-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPRA EPTFE VASCULAR GRAFT |
| Generic Name | EPTFE VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2017-05-02 |
| Catalog Number | 40S06 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-05-02 |