MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-10-14 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 113327MM manufactured by Edwards Lifesciences.
[57562437]
During visual examination, the barrel end was detached from the handle and had a 19mm crack that ran vertically next to the rod to junction region. Three pieces were returned that were broken off from the barrel end. A 2mmx2mm piece was identified to be missing from the barrel end and was not returned. Based on the product evaluation findings the reported condition was confirmed. Manufacturing records were unable to be reviewed as no lot number was provided. With the information received, operational context most likely contributed to this event. No further corrective or preventative actions are required at this time. Edwards will continue to review and monitor all events through the use of edwards quality systems. 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
[57562438]
Edwards was notified that the barrel end of a 27mm sizer fractured while the surgeon was sizing the annulus of a patient. It was reported that strong force was being applied by the surgeon with a forceps. All broken pieces were recovered and the patient was not harmed. The sizer was normal in appearance; however, the sizer was not brand new. The number of uses/sterilization cycles remains unknown. The device was sterilized according to the instructions for use (ifu).
Patient Sequence No: 1, Text Type: D, B5
[63511034]
Through further assessment, the device was manufactured at least 7 years prior to breaking. During product evaluation, it was identified that the barrel end of the sizer had light scratches all over. This is an indication of wear and tear overtime. Therefore, it is possible that the sizer was worn during use and the force applied contributed to the event. The complaint trend was assessed and found to be in control. Trends will continue to be monitored through the use of edwards quality systems.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2016-03062 |
| MDR Report Key | 6031632 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-14 |
| Date of Report | 2016-09-21 |
| Date of Event | 2016-09-21 |
| Date Mfgr Received | 2016-12-16 |
| Date Added to Maude | 2016-10-14 |
| 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 | MR. NEIL LANDRY |
| Manufacturer Street | 1 EDWARDS WAY MS T&D2 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502289 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | 1 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 | SIZER, HEART-VALVE, PROSTHESIS |
| Product Code | DTI |
| Date Received | 2016-10-14 |
| Returned To Mfg | 2016-09-29 |
| Model Number | 113327MM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | 1 EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-14 |