MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2016-11-17 for IMPRA EPTFE VASCULAR GRAFT 40S06 manufactured by Bard Peripheral Vascular, Inc..
[60281348]
No medical records and no medical images were provided to the manufacturer. The device is not available for return. The investigation is currently underway. 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
[60281349]
It was reported that during a clinical trial procedure, approximately ninety five days after the vascular graft was surgically implanted in a right upper arm, the patient experienced alleged thrombosis of the graft, resulting in prolonged hospitalization. It was further reported that the thrombosis was removed, and the event was considered resolved. The patient was discharged from the hospital the following day.
Patient Sequence No: 1, Text Type: D, B5
[61253308]
A manufacturing review was not performed as the lot number was not provided. Visual inspection: the sample was not returned; therefore, visual inspection could not be performed. Functional/performance evaluation: the sample was not returned; therefore, functional/performance evaluation could not be performed. Medical records were not provided; therefore, a review could not be performed. Image/photo review: images/photos were not provided; therefore, a review could not be performed. Conclusion: the device was not returned. Images and medical records were not provided. The investigation was inconclusive for occlusion within the device. Based upon the available information, the definitive root cause was 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. Additional mfr narrative: describe event or problem, relevant tests/lab data, date received by mfr. Other relevant history, brand name, model #/lot #, (b)(4). 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
[61253309]
It was reported that during a clinical trial procedure, approximately ninety five days after the vascular graft was surgically implanted in a right upper arm, the patient experienced alleged thrombosis of the graft, resulting in prolonged hospitalization. It was further reported that the thrombosis was removed, and the event was considered resolved. The patient was discharged from the hospital the following day. New information: it was reported that on (b)(6) 2016, approximately 95 days after the vascular graft was surgically implanted in the right upper arm, the patient allegedly had episodes of arteriovenous (av) fistula blockage, which was being used for dialysis. On the same day, an open thrombectomy; declotting of the right brachial artery axillary vein (avg); and a retrograde fistulogram with brachial artery angiogram were performed. A percutaneous incision was made without an introducer sheath through the graft towards the central venous system, and angioplasty was performed, removing a significant amount of thrombus. After several passes the balloon was upsized and further angioplasty was performed, removing more thrombus, and resulting in better back-bleeding. Additionally, the outflow part of the graft was injected with heparinized saline and clamped. The balloon was reportedly passed once through the graft and angioplasty was performed in the brachial artery, bringing out the proximal plug from the arterial end, and reestablishing inflow. Reportedly, a second pass was not necessary as it was believed the entire thrombus in the upper proximal arterial plug had been removed. There was no reported evidence of distal embolization; therefore, the graft was clamped and the incision was closed. As the graft reportedly had a nice palpable pulse, the graft was cannulated in an ante grade fashion and an ante grade fistulogram was performed with central venographed interpretation. The venous anastomosis was patent without evidence of stenosis, and the axillary and subclavian veins were widely patent. There was reportedly an area of narrowing at the turn down of the subclavian vein into the innominate vein of about thirty percent; however, it was determined this was not hemodynamically significant and did not require treatment. Therefore, the wound was irrigated, all small bleeding points had stopped, and the site was secured. The patient was hemodynamically stable at the conclusion of the procedure and was discharged from the hospital the following day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-01079 |
| MDR Report Key | 6110983 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2016-11-17 |
| Date of Report | 2016-10-24 |
| Date of Event | 2016-09-29 |
| Date Mfgr Received | 2016-11-29 |
| Date Added to Maude | 2016-11-17 |
| 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 | 2016-11-17 |
| Catalog Number | 40S06 |
| 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 | 2016-11-17 |