MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2004-06-14 for VENAFLO EPTFE VASCULAR GRAFT * UNK/VENAFLO manufactured by Bard Peripheral Vascular, Inc..
[21695876]
It was reported that subsequent to a failed cimino fistula in the elbow, a venaflo graft was implanted in the left lower arm between the antecubital artery and basilic vein. One year after implantation, duplex sonography showed "massive calcification" of the graft. Therefore, pta could not be performed. A surgical revision was performed, a 5cm segment of "brittle" graft removed, and an interposition graft was implanted. The graft occluded again. Nine days later the remaining "hardened" graft was replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2004-00057 |
| MDR Report Key | 529854 |
| Report Source | 01 |
| Date Received | 2004-06-14 |
| Date of Report | 2004-05-18 |
| Date of Event | 2004-04-14 |
| Date Mfgr Received | 2004-05-18 |
| Date Added to Maude | 2004-06-17 |
| 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 | 0 |
| Manufacturer Contact | MARY EDWARDS |
| Manufacturer Street | 1625 WEST 3RD ST. P.O. BOX 1740 |
| Manufacturer City | TEMPE AZ 852801740 |
| Manufacturer Country | US |
| Manufacturer Postal | 852801740 |
| Manufacturer Phone | 4808949515 |
| Manufacturer G1 | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Street | 1625 WEST 3RD ST. P.O. BOX 1740 |
| Manufacturer City | TEMPE AZ 85280174 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85280 1740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENAFLO EPTFE VASCULAR GRAFT |
| Generic Name | EPTFE CUFFED AV ACCESS GRAFT |
| Product Code | FIQ |
| Date Received | 2004-06-14 |
| Model Number | * |
| Catalog Number | UNK/VENAFLO |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 519082 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 WEST 3RD ST. P.O. BOX 1740 TEMPE AZ 852801740 US |
| Baseline Brand Name | VENAFLO EPTFE VASCULAR GRAFT |
| Baseline Generic Name | EPTFE CUFFED AV ACCESS GRAFT |
| Baseline Model No | * |
| Baseline Catalog No | UNK/VENAFLO |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-06-14 |