MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-03-23 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 1133 manufactured by Edwards Lifesciences.
[1914713]
Report indicates that a magna ease aortic sizer broke while sizing, and pieces fell into patient, however the broken pieces were collected and no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[9078769]
All broken pieces were returned with device. Device evaluation summary: as received, the cylindrical end od the subject sizer is detached from the rod. Broken pieces are evident in the polysulfone plastic connection to the handle rod; all the broken pieces are returned. The replica end is attached to the rod and is intact. However, cracks are detected at the polysulfone plastic connection to the handle rod. Additional manufacturer narrative: the root cause of the issue has been identified; corrective and preventive actions are in the process of being implemented. The instructions for use (ifu) included with each edwards bioprosthesis has a description of controls necessary for accessory reuse, including recommended sterilization parameters. The labeling describes that sizers should be examined for signs of wear such as dullness, cracking, crazing and should be replaced if any such deterioration is observed.
Patient Sequence No: 1, Text Type: N, H10
[20593682]
Additional manufacturer narrative: the device history record (dhr) review was not performed because the serial number was unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2011-15058 |
| MDR Report Key | 2027987 |
| Report Source | 05,06,07 |
| Date Received | 2011-03-23 |
| Date of Report | 2011-02-22 |
| Date of Event | 2011-02-22 |
| Date Facility Aware | 2011-02-22 |
| Report Date | 2011-02-22 |
| Date Reported to Mfgr | 2011-02-22 |
| Date Mfgr Received | 2011-04-18 |
| Date Added to Maude | 2011-03-23 |
| 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 | 3 |
| Manufacturer Contact | MR NEIL LANDRY |
| Manufacturer Street | ONE EDWARDS WAY MAILSTOP: MS HVC96 |
| 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 | HEART VALVE BIOPROSTHESIS SIZER |
| Product Code | DTI |
| Date Received | 2011-03-23 |
| Returned To Mfg | 2011-02-22 |
| Model Number | 1133 |
| 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 | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-03-23 |