MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2009-05-07 for PERIMOUNT MAGNA EASE AORTIC SIZER 1133 manufactured by Edwards Lifesciences.
[1158050]
Reportedly, device cracked after repeated sterilizations. Being returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[15990102]
Device evaluation: the cylindrical end and the replica end exhibited cracks at the polyphenylsulfone plastic connection to the handle rod. Only the cylindfical end is attached to the rod. Broken piece is detected at the replica end. Additional information: this evaluation supports the customers claim. Safety risk was evaluated and product risk assessment was conducted. As a result of the risk assessment, capa was opened and has addressed this issue. Customer has been apprised of these actions through follow up correspondence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2009-10489 |
| MDR Report Key | 1375023 |
| Report Source | 01,06,07 |
| Date Received | 2009-05-07 |
| Date of Report | 2009-04-06 |
| Date of Event | 2009-04-06 |
| Date Facility Aware | 2009-04-06 |
| Date Mfgr Received | 2009-06-12 |
| Date Added to Maude | 2009-06-22 |
| 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 | PERIMOUNT MAGNA EASE AORTIC SIZER |
| Generic Name | SIZER, HEART-VALVE, PROSTHESIS |
| Product Code | DTI |
| Date Received | 2009-05-07 |
| Returned To Mfg | 2009-04-09 |
| 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 | 2009-05-07 |