MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2016-09-29 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 1130 manufactured by Edwards Lifesciences.
[55945772]
(b)(4). The valve sizer was not returned to edwards for analysis as it is not the hospital's practice to return. However, pictures were provided of the broken sizer and an evaluation of the images is currently pending. A supplemental report will be submitted upon completion.
Patient Sequence No: 1, Text Type: N, H10
[55945773]
Edwards received information that during the procedure, this 21mm aortic valve sizer broke. As reported, the surgeon was sizing the valve when the sizer fractured. All pieces were retrieved and there were no reported complications/adverse events to the patient as a result. The sizer is sterilized using steam and it is unknown how long the sizer had been in use.
Patient Sequence No: 1, Text Type: D, B5
[58831583]
Evaluation summary: the device was not returned for evaluation. However, the customer provided 8 color images of the broken sizer; size 21mm. 5 images of the sizer at different angles, 2 images of the sizer with the fragment, and 1 close up image of the fragment. The barrel end of the sizer was broken at the rod to sizer junction region; one fragment was broke off. Images of the sizer handle were not provided. Additional manufacturer narrative: the customer report of sizer broke off was confirmed through image evaluation. 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. It is unknown in this case how long the sizer had been in use. There is no serial number or lot number available for this device; therefore, the device history record (dhr) review cannot be done. 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
| Report Number | 2015691-2016-02883 |
| MDR Report Key | 5987781 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2016-09-29 |
| Date of Report | 2016-09-05 |
| Date of Event | 2016-05-31 |
| Date Mfgr Received | 2016-10-04 |
| Date Added to Maude | 2016-09-29 |
| 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 | 1 EDWARDS WAY MS: T&D 2ND FLOOR, OFFICE T223 |
| 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 | 2016-09-29 |
| Model Number | 1130 |
| 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 | 2016-09-29 |