MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2014-11-07 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 1150 manufactured by Edwards Lifesciences.
[15813564]
Edwards lifesciences maintains an implant patient registry. This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry. Through the registry, edwards is notified when these devices are implanted. In addition, patient and/or device status may be reported to the registry via the implantation data cards. The information is received from various sources (e. G. Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint". The information reported may or may not be related to the edwards device. In this case, edwards received information that during implantation of an annuloplasty ring, the surgeon broke the handle through "improper use" and not due to a manufacturing defect. According to the operating room, the surgeon held the handle "somewhere" and as the surgeon was placing the ring, the handle broke. The handle and ring were discarded.
Patient Sequence No: 1, Text Type: D, B5
[15958187]
Device not returned. The annuloplasty ring sizer was not returned to edwards for analysis because it was discarded at the hospital. Without return of the device, edwards is unable to conclusively determine the root cause for this event. The site indicated the breakage of the handle was not due to a device malfunction, but due to technical error; as well, there was no report of patient injury as a result of this breakage. Edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2014-02642 |
| MDR Report Key | 4237991 |
| Report Source | 00,05,06 |
| Date Received | 2014-11-07 |
| Date of Report | 2014-10-10 |
| Date of Event | 2014-10-03 |
| Date Mfgr Received | 2014-10-10 |
| Date Added to Maude | 2014-11-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. NEIL LANDRY |
| Manufacturer Street | 1 EDWARDS WAY MS: LFS 33 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502289 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER |
| Generic Name | ANNULOPLASTY RING SIZER |
| Product Code | DTI |
| Date Received | 2014-11-07 |
| Model Number | 1150 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2014-11-07 |