MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-11-09 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 1130 manufactured by Edwards Lifesciences.
[59580724]
Additional manufacturer narrative: handles or sizers that fragment when in use within the operative field have the potential to result in a piece being retained in the heart that could then embolize when the patient's heart begins beating. This has the potential to cause a stroke or myocardial infarction. In this case, all the pieces were able to be recovered and no adverse effects to the patient. Although these devices are reusable, they do not have an indefinite shelf life. According to the directions in the instructions for use (ifu) supplied with the accessories, sizers and sizer handles must be disassembled before resterilization. The accessories should be examined for signs of wear, such as dullness, cracking, or crazing, and do not use if deterioration is observed. In this case, it is unknown how long the sizer had been in use. The device return is in progress. Without the return of the device, the root cause remains indeterminable. If new information is received, a supplemental report will be submitted. No corrective action is applicable to this case; however, edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed. No corrective or preventative actions are required.
Patient Sequence No: 1, Text Type: N, H10
[59580805]
Edwards received information that a 29 mm sizer broke while handling it to size an aortic valve. There was no injury to the patient as a result of the broken sizer and all the pieces were retrieved. It is unknown how long this sizer had been in use. Per the customer, there is no lot number visible on the handle.
Patient Sequence No: 1, Text Type: D, B5
[63302922]
Evaluation summary: as received, the barrel end was detached from the handle. The barrel end had a 8 mm x 10 mm piece that broke off at the rod to sizer junction region. The broken piece matched up to the barrel. The replica end had multiple crazing and two 13 mm cracks that ran vertically next to the rod to sizer junction region. There did not appear to be any missing pieces. Engineering task will be opened for further evaluation. Product appeared in the same condition as in the image provided by the customer. Customer report of broken sizer was confirmed. The root cause of the event remains indeterminable. However, the age of the sizer may have contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2016-03330 |
| MDR Report Key | 6091458 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-09 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-10-19 |
| Date Mfgr Received | 2016-11-30 |
| Date Added to Maude | 2016-11-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NEIL LANDRY |
| Manufacturer Street | ONE EDWARDS WAY M/S MLE-2 |
| 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 | ANNULOPLASTY RING SIZER |
| Product Code | DTI |
| Date Received | 2016-11-09 |
| Returned To Mfg | 2016-11-21 |
| Model Number | 1130 |
| 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 | 2016-11-09 |