MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-01-23 for PULMONARY VALVE & CONDUIT SG SGPV00 manufactured by Cryolife, Inc..
[133904117]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[133904118]
According to initial reports, cryolife sgpv00, serial number: (b)(4) was implanted on (b)(6) 2018 as an rv to pa conduit. The patient passed away on (b)(6) 2018 due to cardiac failure.
Patient Sequence No: 1, Text Type: D, B5
[137557296]
The processing records for sgpv00, serial number (b)(4) were reviewed and it was determined that all attributes identified were documented appropriately and the allograft met specifications. The previous sano shunt was removed and replaced with an sgpv sano shunt. The patient? S medical history contained acute heart failure, aortic stenosis, cyanosis, double outlet right ventricle; truncus arteriosus type 4, dysplastic aortic valve, left coronary artery stenosis, patent ductus arteriosus, pulmonary atresia, and ventricular septal defect. The use of valved homografts as rv-pa conduits in stage i of the modified norwood procedure has been described in literature and has increased in popularity over the bt shunt due to improved outcomes relating to increased postoperative hemodynamic stability (reinhartz 2006, shinkawa 2015, christenson 2010). The patient? S history of severe congenital heart disease, abnormal cardiac anatomy, and failed sano shunt were likely contributing factors to the reported cause of death as cardiac failure. There is no indication that an error or deficiency occurred at cryolife. The risk management file thoroughly identifies the process and product hazards for approved indications. Each individual hazard is mitigated and reduced as low as possible by design and process. This event does not identify additional hazards or modify the probability and severity of existing hazards.
Patient Sequence No: 1, Text Type: N, H10
[137557297]
According to initial reports, cryolife sgpv00 serial number: (b)(4) was implanted on (b)(6) 2018 as an rv to pa conduit. The patient passed away on (b)(6) 2018 due to cardiac failure. No additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00003 |
| MDR Report Key | 8272100 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-01-23 |
| Date of Report | 2019-02-18 |
| Date of Event | 2018-11-03 |
| Date Facility Aware | 2018-12-28 |
| Date Mfgr Received | 2018-12-28 |
| Date Added to Maude | 2019-01-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2019-01-23 |
| Model Number | SGPV00 |
| Catalog Number | SGPV00 |
| Lot Number | 146707 |
| 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. Death | 2019-01-23 |