MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-09-25 for CARPENTIER-EDWARDS PERICARDIAL VALVE SIZER 1127 manufactured by Edwards Lifesciences.
[19294322]
This report was received via a user facility medwatch #(b)(4) forwarded by the fda to edwards lifesciences. Event description in the provided report states, " aortic valve sizer broke when being passed to surgeon. All pieces fell on floor new set of sizers opened. The product is a reusable sizer for aortic valves. It is not a implant. Product may have been at the end of its useful life. No harm to patient or staff. Another set of sizers was obtained and the case continued without incident. The age of the sizers is unknown. " it was learned that the subject sizers were discarded and not available for return. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
[19471959]
The subject sizer model 1127 is supplied with carpentier-edwards perimount aortic pericardial bioprosthesis model 2700. As indicated on the subject device's product labeling, information for use, " sizers and handles are supplied nonsterile and must be sterilized before using. They must be disassembled, cleaned and resterilized prior to each successive use. Sizers and handles are intended for multiple use as long as they are properly handled and inspected prior to each use. Sizers and handles should be examined for signs of wear, such as dullness, cracking or crazing, and should be replaced if any deterioration is observed. " product labeling also contains recommended conditions for sterilization of the subject sizers. Per follow up with the hospital, it was learned that the sizer in question was discarded during the case; therefore, device evaluation could not be completed. Edwards performed multiple follow ups to obtain the hospital sterilization methods, in addition to the number of uses of the subject sizer; no information was provided. Review of complaint database for the last two years indicates no similar events received for the sizer model number in question. Per the provided information and edwards investigation, it is likely that this event is related to wear and tear of the reusable sizer (multiple sterilization cycles), and failure by the user (surgical staff) to properly examine the device prior to use. No information to suggest a device quality deficiency related to this event, and no further action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2013-21156 |
| MDR Report Key | 3368751 |
| Report Source | 06,07 |
| Date Received | 2013-09-25 |
| Date of Report | 2013-08-27 |
| Date of Event | 2013-06-07 |
| Date Mfgr Received | 2014-11-05 |
| Date Added to Maude | 2014-01-03 |
| 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 | 0 |
| Manufacturer Contact | MR. NEIL LANDRY |
| Manufacturer Street | 1 EDWARDS WAY MS: LFS 33 |
| 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 PERICARDIAL VALVE SIZER |
| Generic Name | SIZER, HEART-VALVE, PROSTHESIS |
| Product Code | DTI |
| Date Received | 2013-09-25 |
| Model Number | 1127 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-09-25 |