MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-01-06 for SYNERGRAFT PULMONARY VALVE AND CONDUIT SGPV00 manufactured by Cryolife, Inc..
[64033471]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[64033472]
According to the email from the surgeon, "we had some cracks in the muscle of the homograft again but i was able to work around them ok. I didn't expect to do a ross because she has a bicuspid pulmonary valve but i couldn't re-repair her so i did it anyway. It worked very nicely. "
Patient Sequence No: 1, Text Type: D, B5
[69982389]
Attempts were made to obtain additional information including whether there was a delay in the procedure and whether the proper handling, storage, and thaw and rinse processes were performed. No further information was available. The cryolife representative was able to speak to the surgeon and stated "he tried to downplay the situation and felt like it was no big deal. It did not increase his surgery time. " a review was performed of the available information. The allograft was not returned so no direct observations could be made. A review of training records indicates that the technicians who handled this allograft while in the frozen state were appropriately trained for the tasks they performed. There are no allograft-specific non-conformances associated with this tissue. There are no non-conformances associated with the transfer or handling of this allograft. No deviations were identified during a review of the tissue transfer logs and the packaging inspection sheet. . The allograft was shipped to (b)(6) med ctr via (b)(6) on 10/05/2016 for priority overnight. Prior to the shipment of this allograft, there were no abnormalities noted on the outer packaging. There were no incident reports filed in the courier database for (b)(6) during transit/delivery of this allograft. No findings were identified that could have contributed to the reported event. As the allograft was not returned for evaluation a definitive root cause cannot be determined; however, the issue noted by the complainant may have been caused by mishandling the packaged allograft while in the frozen state. The ifu provides the following instructions: "cryopreserved allografts are fragile and must be handled with care while in the frozen state to avoid causing damage to allograft or packaging," "valve may be damaged or the integrity of the pouch may be compromised if not properly handled. Do not implant the cryovalve sg:... If the package has been handled with sharp instruments, dropped while at cryogenic temperatures, or otherwise mishandled," and "the cardiac thawing and rinsing instructions must be followed exactly to minimize physical damage to the valve. " the unpacking instructions shipped with each allograft state: "if an allograft is to be stored in a low temperature storage freezer (at or below -135? C), locate an empty slot in the racking system that is not exposed to liquid nitrogen and carefully place the allograft into the empty slot. The allograft should remain in the cardboard box throughout the duration of the allograft's storage at the facility. " device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[69982390]
According to the email from the surgeon, "we had some cracks in the muscle of the homograft again but i was able to work around them ok. I didn't expect to do a ross because she has a bicuspid pulmonary valve but i couldn't re-repair her so i did it anyway. It worked very nicely. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00001 |
| MDR Report Key | 6228420 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-01-06 |
| Date of Report | 2017-03-13 |
| Date of Event | 2016-12-07 |
| Date Facility Aware | 2016-12-07 |
| Date Mfgr Received | 2016-12-07 |
| Device Manufacturer Date | 2015-12-10 |
| Date Added to Maude | 2017-01-06 |
| 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., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| 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 | SYNERGRAFT PULMONARY VALVE AND CONDUIT |
| Generic Name | HEART VALVE |
| Product Code | OHA |
| Date Received | 2017-01-06 |
| Model Number | SGPV00 |
| Lot Number | 136565 |
| 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 | 2017-01-06 |