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 2019-02-14 for PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM PFP0.8X8 manufactured by Cryolife, Inc. ? Kennesaw.
[136138999]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[136139000]
According to initial reports, the patient had a left carotid endarterectomy on (b)(6) 2018. A pfpo. 8x8, lot # 31090718 was used. There were no difficulties and the patient was discharged on (b)(6) 2018. She came back to the emergency department (b)(6) 2019: the surgeon was on call for the weekend and took the patient to surgery emergently at 02:15 on (b)(6) 2019. There was 1200 cc blood loss. The surgeon repaired the artery with a lemaitre xenosure 1x6. There was no sign of infection and the surgeon states that half of the original patch placed on (b)(6) was missing as if it had disintegrated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00006 |
| MDR Report Key | 8339250 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-14 |
| Date of Report | 2019-05-04 |
| Date of Event | 2019-01-21 |
| Date Facility Aware | 2019-02-05 |
| Date Mfgr Received | 2019-02-05 |
| Date Added to Maude | 2019-02-14 |
| 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 | 2019-02-14 |
| Model Number | PFP0.8X8 |
| Lot Number | 31090718 |
| 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. Required No Informationntervention | 2019-02-14 |