N
Patient 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
MAUDE MDR 8374288
- MDR report key
- 8374288
- Report number
- 1063481-2019-00008
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-02-27
- Date received
- 2019-02-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ROCHELLE MANEY
- Address
- 1655 ROBERTS BLVD KENNESAW GA 30144 US
- Phone
- 770-770-7704
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE | CRYOLIFE, INC. ? KENNESAW | DXZ | PFP 6X8 | PFP 6X8 | 11062618 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-27 | 0 | 1. H; 2. L; 3. O; 4. R |
Event Narratives#
D
Patient 1
ACCORDING TO INITIAL REPORTS, PATIENT EXPERIENCED HYPERSENSITIVITY THOUGHT TO BE ATTRIBUTED TO PHOTOFIX. DATE OF IMPLANT (B)(6) 2018. ADDITIONAL INFORMATION RECEIVED. THE PATIENT ENDED UP HAVING A LARGE CLOT FORM ON THE INTER-ATRIAL BAFFLE PATCH DURING THE MONTH OF DEC DESPITE BEING ON THERAPEUTIC COUMADIN. THE CLOT HAD TO BE SURGICALLY REMOVED IN (B)(6) 2019. THEN, DESPITE RUNNING HIS INR EVEN HIGHER IN THE INR 2.5-4 RANGE ON COUMADIN WITH 325 MG ASPIRIN, THE GROWTH HAS CONTINUED TO GROW ON HIS ATRIAL BAFFLE AND IT CHANGES EVERY WEEK, SO WE NOW HAVE TO REMOVE THE ENTIRE BAFFLE FOR TAKE DOWN TO USE A DIFFERENT TYPE OF PATCH MATERIAL.