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 2009-05-02 for PERIMOUNT MAGNA EASE AORTIC SIZER 1133 manufactured by Edwards Lifesciences.
[1127358]
Reportedly, after sterilization, lot of damages occurred on sizers surface and at the connection sites with the shaft. So, the head nurse does not feel comfortable to provide them to the doctors, asks for replacement by edwards distributor. This device was received in 2009. Through follow up with the hospital, it was learned that the sizers are routinely cleaned by brushing and then sterilized approx 6-7 timer per week using mild additives with enzyme, cycle 250f 30 minutes, autoclave, prevacuum. These sizers were put into place in 2008, and had been used for several months. The damage was described as "cracks from the center to periphery and the surface had been dimmed. " this was noticed after 2-3 months of usage. The hospital is asking for a replacement of sizers on a monthly basis. A capa was opened to address the issue of cracking and breaking in the 1133 sizers and the investigation is ongoing. No additional information is available at this time. Since these devices are not serialized, no device history record (dhr) review can be done.
Patient Sequence No: 1, Text Type: D, B5
[8393623]
Evaluation summary: 2009, the cylindrical end and the replica end exhibited cracks at the polysulfone plastic connection to the handle rod. Only the replica end remained attached to the handle rod. No visible broken pieces were detected from the sizers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2009-10453 |
| MDR Report Key | 1372826 |
| Report Source | 01,05,06,07 |
| Date Received | 2009-05-02 |
| Date of Report | 2009-04-02 |
| Date of Event | 2009-03-03 |
| Date Facility Aware | 2009-03-03 |
| Date Mfgr Received | 2009-04-22 |
| Date Added to Maude | 2009-05-02 |
| 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 | REPLACEMENT HEART VALVE SIZER |
| Product Code | DTI |
| Date Received | 2009-05-02 |
| Returned To Mfg | 2009-04-21 |
| Model Number | 1133 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2009-05-02 |