MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-16 for CRYOVALVE SG PULMONARY HEART VALVE AND CONDUIT SGPV00 manufactured by Cryolife, Inc..
[1429489]
Approximately seven years after implant of the heart valve, a fungal vegetation reportedly developed in the conduit. However, the surgeon does not believe the organism was introduced by the allograft or at the time of implant.
Patient Sequence No: 1, Text Type: D, B5
[8707270]
An investigation into the reported event has been initiated. This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event. Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
Patient Sequence No: 1, Text Type: N, H10
[8847829]
According to the report, the patient received pulmonary valve and conduit sg as a replacement for a previously implanted allograft (no record of previous implant) that was explanted due to pulmonary insufficiency. Approximately seven years after implant of the allograft, it was explanted due to fungal vegetations within the allograft. As such, an investigation was performed. A review of the monitoring records indicates that each technician who handled this allograft was appropriately qualified for the task she or he performed. A review of the processing records indicates that this allograft was processed according to applicable procedures. A review of the donor records showed that the donor showed no evidence of systemic infection or disseminated contamination. The cause of the reported event can not be determined from the available information. However, given the time interval between the implant and the reported event, contamination of the graft prior to implant would be exceedingly unlikely. In addition, the surgeon did not feel that the organism was introduced by the allograft. No further action is warranted at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1063481-2010-00035 |
| MDR Report Key | 1837319 |
| Report Source | 05 |
| Date Received | 2010-09-16 |
| Date of Report | 2010-09-16 |
| Date Mfgr Received | 2010-09-15 |
| Device Manufacturer Date | 2002-05-10 |
| Date Added to Maude | 2010-09-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. BRYAN BROSSEAU |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| 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 | CRYOVALVE SG PULMONARY HEART VALVE AND CONDUIT |
| Generic Name | HEART VALVE |
| Product Code | OHA |
| Date Received | 2010-09-16 |
| Model Number | SGPV00 |
| Lot Number | N/A |
| Device Expiration Date | 2012-01-01 |
| Operator | PHYSICIAN |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2010-09-16 |