MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,06 report with the FDA on 2011-03-10 for AORTIC VALVE & CONDUIT SG SGAV00 manufactured by Cryolife, Inc..
[1924032]
As part of the cryovalve sg aortic human heart valve retrospective/prospective, multi-center cohort study, an explant form indicating the following event was received. According to the report, 4. 6 years after implant of the synergraft aortic valve and conduit allograft the allograft was explanted due to structural deterioration, calcification, and insufficiency, stenosis or obstruction of the allograft conduit, and stenosis or obstruction of the valve. The operative notes indicate there was moderately severe aortic allograft insufficiency with moderate aortic stenosis.
Patient Sequence No: 1, Text Type: D, B5
[9100484]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[9403289]
According to the report, 4. 6 years after implant of synergraft aortic valve & conduit allograft the allograft was explanted due to structural deterioration, calcification, insufficiency, stenosis/obstruction of allograft conduit, and stenosis/obstruction of the valve. The operative notes indicate there was moderately severe aortic allograft insufficiency with moderate aortic stenosis. The hospital indicated that the event was due to a failure of the allograft. The allograft was not returned so no direct observations can be made. A review of the processing records indicates that allograft met all processing specifications prior to release. A review of relevant literature indicates that although explantation of the valve approximately 4. 5 years after implant due to unacceptable hemodynamics could be considered early. However, it has been reported in the literature and is a known complication after cardiac valve implantation. It should also be noted that this patient received three previous aortic valve replacements prior to this procedure. The precise cause of the event cannot be determined from the available information; however, the report is consistent with features of structural valve deterioration. Structural valve deterioration is a known potential complication and is known to occur at an accelerated rate in the pediatric population. No further action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1063481-2011-00010 |
| MDR Report Key | 2013240 |
| Report Source | 02,05,06 |
| Date Received | 2011-03-10 |
| Date of Report | 2011-03-09 |
| Date of Event | 2009-08-10 |
| Date Mfgr Received | 2011-02-23 |
| Device Manufacturer Date | 2002-04-12 |
| Date Added to Maude | 2011-03-11 |
| 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 | AORTIC VALVE & CONDUIT SG |
| Generic Name | CARDIAC ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2011-03-10 |
| Model Number | SGAV00 |
| ID Number | 63137 (DONOR NUMBER) |
| Device Expiration Date | 2012-04-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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. Other | 2011-03-10 |