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 2017-03-21 for IMPRA VASCULAR GRAFT 40S06 manufactured by Bard Peripheral Vascular, Inc..
[70515500]
No medical records or no medical images have been made available to the manufacturer. As the lot number for the device was not provided, a review of the device history records could not be performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. Clinical trial review: an arteriovenous (av) graft was placed in the left upper arm as a study conduit for a clinical trial. Approximately seven weeks post av graft placement, the patient presented with injury to the axillary vein and a stent graft was placed. Approximately two and a half months post av graft placement, the patient presented with vascular access thrombosis. The patient underwent an open thrombectomy and was able to receive dialysis after the procedure. The following day, the patient experienced vascular access thrombosis and stenosis and underwent another open thrombectomy. A phlebograpy demonstrated stenosis near the venous anastomosis; therefore, angioplasty was performed utilizing a plain balloon to repair the small damage of the axillary vein. A control phlebograpy was then performed demonstrating very good inflow without stenosis or leaks. After the procedure the patient was dialyzed successfully. Two days later, the patient was discharged from the hospital. 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
[70515501]
It was reported through the results of a clinical trial, that approximately two and one half months post placement of a left upper arm arteriovenous expanded polytetrafluoroethylene graft, the patient presented with vascular access thrombosis. An open thrombectomy was performed and the patient was able to receive dialysis after the procedure. The following day, the patient experienced vascular access thrombosis and stenosis and another open thrombectomy was performed. Imaging demonstrated stenosis near the venous anastomosis and angioplasty of the axillary vein was performed. Post procedure imaging demonstrated good inflow without stenosis or leaks and dialysis was successful after the procedure. Two days later, the patient was discharged from the hospital.
Patient Sequence No: 1, Text Type: D, B5
[74378368]
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. Clinical trial results review: an arteriovenous (av) graft was placed in the left upper arm as a study conduit for a clinical trial. Approximately seven weeks post av graft placement, the patient presented with injury to the axillary vein and a stent graft was placed. Approximately two and a half months post av graft placement, the patient presented with vascular access thrombosis. The patient underwent an open thrombectomy and was able to receive dialysis after the procedure. The following day, the patient experienced vascular access thrombosis and stenosis and underwent another open thrombectomy. A phlebography demonstrated stenosis near the venous anastomosis; therefore, angioplasty was performed utilizing a plain balloon to repair the small damage of the axillary vein. A control phlebography was then performed demonstrating very good inflow without stenosis or leaks. After the procedure the patient was dialyzed successfully. Two days later, the patient was discharged from the hospital. Approximately five months post av graft placement, following a dialysis treatment, no thrill or bruit was found. The patient was found to have vascular access thrombosis, was admitted to the hospital and a thrombectomy was performed. Image/photo review: as medical images were not provided, a review could not be performed. Conclusion: the device was not returned for evaluation. Images were not provided for reviewed. Clinical trial summary was provided and reviewed. The investigation is inconclusive for the reported occlusion of the device, as the actual medical records were not provided for review. 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
[74378369]
It was reported through the results of a clinical trial, that approximately two and one half months post placement of a left upper arm arteriovenous expanded polytetrafluoroethylene graft, the patient presented with vascular access thrombosis. An open thrombectomy was performed and the patient was able to receive dialysis after the procedure. The following day, the patient experienced vascular access thrombosis and stenosis and another open thrombectomy was performed. Imaging demonstrated stenosis near the venous anastomosis and angioplasty of the axillary vein was performed. Post procedure imaging demonstrated good inflow without stenosis or leaks and dialysis was successful after the procedure. Two days later, the patient was discharged from the hospital. New information received: approximately five months post av graft placement, the patient was found to have vascular access thrombosis, was admitted to the hospital and a thrombectomy was performed.
Patient Sequence No: 1, Text Type: D, B5
[113548578]
Manufacturing review: device history record (dhr) for lot number vtap0037 was reviewed and the lot met all release criteria. The dhr review showed that all process parameters were within specification and that this lot of grafts passed all physical testing requirements. Investigation summary: the device was not returned for evaluation. Images and medical records were not provided for review. Therefore, the investigation is inconclusive for the alleged occlusion as no objective evidence has been provided to confirm any alleged deficiency with the device. Based upon the available information, the definitive root cause is unknown. Labeling review: a review of product labeling documents (e. G. Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate. 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
[113548579]
It was reported through the results of a clinical trial, approximately 330 days post study conduit insertion, the subject experienced thrombosis of vascular access detected during dialysis session and was admitted to the hospital surgical ward. Thrombectomy was performed. Approximately 331 days post study conduit insertion, the subject experienced a second event of thrombosis of vascular access and stenosis of vascular access which prolonged hospitalization. An access angiogram, angioplasty and mechanical thrombectomy were performed. Angiogram revealed stenosis of axillary vein. An angioplasty was performed of the draining vein using a drug-coated balloon with good outcome and the subject dialyzed using the study conduit. Approximately 332 days post study conduit insertion, the subject experienced a third event of thrombosis of vascular access which prolonged hospitalization. Approximately 333 days post study conduit insertion, the subject experienced a second event of stenosis of vascular access. Thrombectomy was performed for the event of thrombosis of vascular access and the event was considered resolved. A repeat angiogram revealed stenosis in the axillary vein. An angioplasty was performed for the event of stenosis of vascular access using plain balloons and the event was considered resolved. Status of admission was not provided. New information received: it was reported through the results of a clinical trial, approximately 487 days post study conduit insertion, the subject experienced thrombosis of vascular access and was admitted to the hospital vascular surgery unit. Thrombectomy with venography was performed the next day, which revealed stenosis in the left axillary and subclavian vein. Successful percutaneous transluminal angioplasty (pta) was completed and a covered stent was implanted. Approximately 489 days post study conduit insertion, the subject was discharged from the hospital and the event was considered resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2017-00231 |
| MDR Report Key | 6423070 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2017-03-21 |
| Date of Report | 2019-02-14 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2019-02-02 |
| Date Added to Maude | 2017-03-21 |
| 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 VASCULAR GRAFT |
| Generic Name | EPTFE VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2017-03-21 |
| 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 | 2017-03-21 |