MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-07-17 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 1133 manufactured by Edwards Lifesciences.
[6010136]
Edwards received information that a surgeon bent the 25mm sizer in order to be inserted into the patient's aorta, and the plastic part of the handle which connects to the metal section had snapped away. A piece of plastic from the sizer's handle was dislodged onto the field. It was unknown whether the dislodged plastic piece came in contact with the patient.
Patient Sequence No: 1, Text Type: D, B5
[6053713]
Through follow up, it was learned that the plastic section of the sizer end which connects to the metal section had snapped away.
Patient Sequence No: 1, Text Type: D, B5
[14029235]
Method: device not returned. Additional manufacturer narrative: 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 re-sterilization. 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, the maintenance and usage information has been requested but not received. The device has not been returned for evaluation and follow up attempts to obtain the device and further information are in progress. Therefore, we are unable to confirm the clinical report or investigate further into the root cause for fracture of this device. Should new information or the complaint device is received at a later date, a supplemental mdr will be submitted. 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.
Patient Sequence No: 1, Text Type: N, H10
[14380875]
Through follow up, it was learned that the device is no longer available for return. Photographs were requested but the hospital confirmed that they cannot provide the photographs to edwards.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2015-01741 |
| MDR Report Key | 4922136 |
| Report Source | 05,06,07 |
| Date Received | 2015-07-17 |
| Date of Report | 2015-06-24 |
| Date of Event | 2015-06-24 |
| Date Mfgr Received | 2015-07-17 |
| Date Added to Maude | 2015-07-17 |
| 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 MLE-8 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502289 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | 1 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 | SIZER, HEART-VALVE, PROSTHESIS |
| Product Code | DTI |
| Date Received | 2015-07-17 |
| Model Number | 1133 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2015-07-17 |