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 2017-05-30 for SG PULMONARY VALVE & CONDUIT SGPV00 manufactured by Cryolife, Inc..
[76148060]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[76148061]
According to the initial report, "approximately one year ago, a patient implanted with? Sg pulmonary valve and conduit required surgical intervention due to a reported "premature failure"; the failure, reported from the surgeon, is believed to be an immunologic response to the implant of the valve.
Patient Sequence No: 1, Text Type: D, B5
[79047099]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[79047100]
According to the initial report, "approximately (b)(6), a patient implanted with sg pulmonary valve and conduit required surgical intervention due to a reported "premature failure"; the failure, reported from the surgeon, is believed to be an immunologic response to the implant of the valve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00018 |
| MDR Report Key | 6597487 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-05-30 |
| Date of Report | 2017-07-31 |
| Date of Event | 2017-05-17 |
| Date Facility Aware | 2017-05-01 |
| Date Mfgr Received | 2017-05-01 |
| Device Manufacturer Date | 2015-10-07 |
| Date Added to Maude | 2017-05-30 |
| 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 | SG PULMONARY VALVE & CONDUIT |
| Generic Name | HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2017-05-30 |
| Returned To Mfg | 2017-05-18 |
| Model Number | SGPV00 |
| Catalog Number | SGPV00 |
| Lot Number | 133999 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2017-05-30 |