MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-27 for PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM PFP 6X8 manufactured by Cryolife, Inc. ? Kennesaw.
[137274508]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[137274509]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00008 |
| MDR Report Key | 8374288 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-27 |
| Date of Report | 2019-05-04 |
| Date of Event | 2019-02-27 |
| Date Facility Aware | 2019-02-25 |
| Date Mfgr Received | 2019-02-25 |
| Date Added to Maude | 2019-02-27 |
| 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 | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM |
| Generic Name | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE |
| Product Code | DXZ |
| Date Received | 2019-02-27 |
| Model Number | PFP 6X8 |
| Catalog Number | PFP 6X8 |
| Lot Number | 11062618 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. ? KENNESAW |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2019-02-27 |