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 2016-04-06 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 1133 manufactured by Edwards Lifesciences.
[42000819]
Evaluation summary: as received, the barrel end of the sizer was completely detached from the rod. The barrel end had two pieces broken, both were 10mm in length. The pieces matched up to the barrel, and there did not appear to be any missing pieces. The replica end had 3 crazes seen at the rod to sizer junction. Additional manufacturer narrative: customer report of broken sizer was confirmed. There is no serial number of lot number available for this device; therefore, the device history record (dhr) review cannot be done. 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. The ifu was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device. 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
[42000820]
Edwards received information that a 25mm sizer broke inside the patient during use. All the pieces were able to be recovered and there was no patient injury related to the broken sizer. The patient outcome was reported as, "fine. " the broken sizer was returned for evaluation. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[43863800]
Additional information was obtained through follow up with the healthcare provider. (b)(4). Additional comments were provide by engineering. The root cause of cracking/crazing on the barrel end of the sizer was likely due to the age of the device at the time of use. The device was approximately (b)(6) years old at the time that it broke. It is unknown how many operations the device had been used in, but there are a large amount of visible scratches and indications of heavy wear on both the replica and sizing end.
Patient Sequence No: 1, Text Type: N, H10
[43863801]
Through follow-up with the health care provider, it was learned that a 27mm pericardial valve was implanted and echocardiographic examination revealed a well seated prosthesis with no evidence of paravalvular leak and appropriate leaflet function. The patient was discharged to a rehab facility on post-operative day seven (7). It was also reported by the sterile processing department at the hospital that the broken sizer was steam sterilized per the instructions for use (ifu).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2016-01110 |
| MDR Report Key | 5551891 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-04-06 |
| Date of Report | 2016-04-08 |
| Date of Event | 2016-03-09 |
| Date Mfgr Received | 2016-04-08 |
| Date Added to Maude | 2016-04-06 |
| 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 MLE-8 |
| 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 | 2016-04-06 |
| Returned To Mfg | 2016-03-21 |
| 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 | 2016-04-06 |