D
Patient 1
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.
MAUDE MDR 1837319
- MDR report key
- 1837319
- Report number
- 1063481-2010-00035
- Event key
- 0
- Event type
- 3
- Date received
- 2010-09-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MR. BRYAN BROSSEAU
- Address
- 1655 ROBERTS BLVD. NW 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 | CRYOVALVE SG PULMONARY HEART VALVE AND CONDUIT | HEART VALVE | CRYOLIFE, INC. | OHA | SGPV00 | N/A | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-09-16 | 0 | 1. H; 2. R |
Event Narratives#
N
Patient 1
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.
N
Patient 1
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.