MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2009-07-08 for PERIMOUNT MAGNA EASE AORTIC SIZER 1133 manufactured by Edwards Lifesciences.
[1085632]
Reportedly, the sizer broke after repeated sterilization. Method of sterilization: prevacuum at 121 degrees celsius for 20 minutes. If the sizers are not used they are sterilized every 2 months. After investigation in other hospitals this should not be a reason for failure.
Patient Sequence No: 1, Text Type: D, B5
[8434086]
06/15/2009 per follow up with the affiliate, sizer was broken and will be returned. There is no indication as to how long this device has been in service or how many times it has been used and sterilized. Requested more specific cleaning and sterilization procedure information from the hospital. This was determined to be reportable per edwards lifesciences procedures. This is not a serialized device, therefore, no dhr review can be done. No additional information is available.
Patient Sequence No: 1, Text Type: N, H10
[17596636]
Customer letter with evaluation results has been sent. Device evaluation: the replica end exhibits crazing at polysufone plastic connection to the handle rod. There are no pieces missing form the replica end. The cylindrical end was broken off from the handle. Broken piece was returned, is most likely a section of the cylindrical connection to the handle rod.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2009-11008 |
| MDR Report Key | 1410203 |
| Report Source | 01,05,06,07 |
| Date Received | 2009-07-08 |
| Date of Report | 2009-06-09 |
| Date of Event | 2009-04-01 |
| Date Facility Aware | 2009-06-09 |
| Date Mfgr Received | 2009-08-12 |
| Date Added to Maude | 2009-09-08 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| 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 | PERIMOUNT MAGNA EASE AORTIC SIZER |
| Generic Name | SIZER, HEART-VALVE, PROSTHESIS |
| Product Code | DTI |
| Date Received | 2009-07-08 |
| Returned To Mfg | 2009-07-08 |
| 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 | 2009-07-08 |