MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-05-19 for NONE manufactured by W.l. Gore & Associates.
[1127697]
The following was reported to gore: the patient had mitral valve reconstruction with replacement of the chordae tendineae with gore-tex suture to treat mitral regurgitation in 2003. In 2009, the patient underwent procedure for mitral valve replacement using a mechanical valve. During the replacement procedure, it was observed that one suture was ruptured in two locations. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[8146211]
The investigation is in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003910212-2009-00015 |
| MDR Report Key | 1391768 |
| Report Source | 07 |
| Date Received | 2009-05-19 |
| Date of Report | 2009-05-19 |
| Date of Event | 2009-04-14 |
| Date Mfgr Received | 2009-04-21 |
| Date Added to Maude | 2009-05-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CRAIG BEARCHELL |
| Manufacturer Street | 1500 N FOURTH ST |
| Manufacturer City | FLAGSTAFF AZ 86004 |
| Manufacturer Country | US |
| Manufacturer Postal | 86004 |
| Manufacturer Phone | 9285263030 |
| Manufacturer Street | 301 AIRPORT RD. |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21921 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NONE |
| Generic Name | NONE |
| Product Code | NBY |
| Date Received | 2009-05-19 |
| Returned To Mfg | 2009-04-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | ELKTON MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-05-19 |