MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-11-07 for PULMONARY VALVE & CONDUIT SG SGPV00 manufactured by Cryolife, Inc..
[126357467]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[126357468]
According to the implant summary card received on 10/01/2018, previously implanted cryolife tissue was explanted due to pseudo-aneurysm. Additional information received indicates that serial number (b)(4), an sgpv00 was explanted on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2018-00043 |
| MDR Report Key | 8045569 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-07 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-09-28 |
| Date Facility Aware | 2018-10-10 |
| Date Mfgr Received | 2018-10-10 |
| Date Added to Maude | 2018-11-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-11-07 |
| Model Number | SGPV00 |
| Catalog Number | SGPV00 |
| Lot Number | 143695 |
| 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 | 2018-11-07 |