MAUDE MDR 137785
- MDR report key
- 137785
- Report number
- 2183620-1997-00021
- Event key
- 0
- Event type
- 3
- Date of event
- 1997-08-10
- Date received
- 1997-12-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact
- Report source
- M
- Manufacturer link flag
- Y
Devices
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | PERI-GUARD | PERICARDIAL PATCH | BIO-VASCULAR, INC. | MFX | UNK | UNK | UNK | | | Y | Y | R |
Patients
| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 1997-12-06 | 0 |
|
Event Narratives
N
Patient 1
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.
Related GUDID Devices By Product Code
No records found.
Related PMN/PMA Records By Product Code
| Type | Submission | Product code | Device | Applicant | Decision date |
|---|
| 510(k) | K061727 | MFX | GORE PRECLUDE VESSEL GUARD | W. L. Gore & Associates, Inc. | 2006-08-07 |
| 510(k) | K960532 | MFX | PRECLUDE IMA SLEEVE | W. L. Gore & Associates, Inc. | 1996-05-23 |