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 2019-03-29 for PULMONARY VALVE & CONDUIT SG SGPV00 manufactured by Cryolife, Inc..
[140283929]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[140283930]
According to the implant summary card, previously implanted cryolife tissue was explanted on (b)(6) 2019. Additional information received from the cryolife rep, indicates that a cryolife sgpv00 serial number (sn): (b)(4) was implanted on (b)(6) 2015. Additional information from karen krusinski, rn cardiac or team leader, relayed that the sgpv00 serial number (b)(4) was explanted on (b)(6) 2019 due to stenosis rv-pa conduit. The pre-op diagnosis for the procedure was stenosis rv-pa conduit, aortic atresia, vsd, s/p norwood, s/p rastelli. The procedure performed was pulmonary valve replacement. The patient was discharged home on (b)(6) 2019. No additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00016 |
| MDR Report Key | 8463775 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-29 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-02-14 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-03-29 |
| 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 |
| Product Code | DXZ |
| Date Received | 2019-03-29 |
| Model Number | SGPV00 |
| Device Availability | N |
| 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. Other; 2. Required No Informationntervention | 2019-03-29 |