MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 1997-12-06 for PERI-GUARD UNK manufactured by Bio-vascular, Inc..
[7828844]
The surgeon provided add'l info regarding this incident as follows: the pt experienced a 75% restenosis of an ica 5 1/2 yrs post-implant. The surgeon performed an endoarteriectomy and replaced the peri-guard patch with a vascu-guard patch, lot # vgs-96l17-080 mfg by bio-vascular, inc. The surgeon stated that he does not attribute this incident to the use of the peri-guard tissue patch. No harm came to the pt and the pt is in good condition with no adverse symptoms 4 mos post-explant. An eval of the explant specimen was performed at bio-vascular, inc. The results of the analysis are as follows: the host artery wall appeared to have fused with the patch material without any long-standing inflammation and there was no indication of patch degeneration from cross-sectional histologic views.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183620-1997-00021 |
| MDR Report Key | 137785 |
| Report Source | 01,05 |
| Date Received | 1997-12-06 |
| Date of Report | 1997-12-05 |
| Date of Event | 1997-08-10 |
| Date Mfgr Received | 1997-11-04 |
| Date Added to Maude | 1997-12-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERI-GUARD |
| Generic Name | PERICARDIAL PATCH |
| Product Code | MFX |
| Date Received | 1997-12-06 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 134572 |
| Manufacturer | BIO-VASCULAR, INC. |
| Manufacturer Address | 2575 UNIVERSITY AVE. ST. PAUL MN 551141024 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-12-06 |