MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2018-12-03 for PULMONARY VALVE & CONDUIT SG SGPV00 manufactured by Cryolife, Inc..
[129046544]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[129046545]
According to the implant summary card received, previously implanted cryolife tissue was explanted on (b)(6) 2018. A query of the implant database revealed that sgpv00, serial number: (b)(4) was implanted on (b)(6) 2014. Additional information received revealed that the sgpv00 serial number: (b)(4) was explanted due to endocarditis. The allograft was implanted on (b)(6) 2014 due to endocarditis. The patient was discharged without issue. The hospital will not release operative notes for any of the surgical procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2018-00047 |
| MDR Report Key | 8124630 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-12-03 |
| Date of Report | 2019-01-22 |
| Date of Event | 2018-10-17 |
| Date Facility Aware | 2018-11-06 |
| Date Mfgr Received | 2018-11-06 |
| Date Added to Maude | 2018-12-03 |
| 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 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 | PULMONARY VALVE & CONDUIT SG |
| Generic Name | HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2018-12-03 |
| Model Number | SGPV00 |
| Catalog Number | SGPV00 |
| Lot Number | 126870 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Life Threatening | 2018-12-03 |