MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,study, report with the FDA on 2019-05-29 for PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM PF UNK manufactured by Cryolife, Inc..
[146398313]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[146398314]
Patient with tricuspid anatomy who underwent an aortic valve reconstruction utilizing the ozaki procedure with photofix (off-label use) required re-operation due to both surfaces of the leaflet being heavily calcified with pink/tan excrescences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00032 |
| MDR Report Key | 8650666 |
| Report Source | COMPANY REPRESENTATIVE,STUDY, |
| Date Received | 2019-05-29 |
| Date of Report | 2019-07-08 |
| Date of Event | 2019-05-29 |
| Date Mfgr Received | 2019-05-04 |
| Date Added to Maude | 2019-05-29 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM |
| Generic Name | PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM |
| Product Code | PSQ |
| Date Received | 2019-05-29 |
| Model Number | PF UNK |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| 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 | 2019-05-29 |