MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-16 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 116123MM manufactured by Edwards Lifesciences.
[114558833]
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. As per the reported information, it was believed that the device had gone through at least 150 sterilization cycles. The product instructions for use (ifu) list time and temperature guidelines as well as equipment and solution recommendations for by hand and by machine cleaning and sterilization. Included in the ifu is the following statement: "caution: examine sizers and handles for signs of wear, such as dullness, cracking or crazing. Replace sizer/handle if any deterioration is observed. " this inspection is done prior to cleaning and sterilization and should prevent breakages during use. The sizer has not been returned at this time. Therefore, the event is unable to be confirmed at this time. The root cause of the event remains indeterminable. A supplemental report will be submitted if new information is received.
Patient Sequence No: 1, Text Type: N, H10
[114558834]
Edwards received notification that during the sizing of the annulus in the avr replacement procedure, the surgeon noticed a piece of the body of the 23mm sizer had broken off. As reported, normal force was applied in this case. The surgeon located the fragment in the lv and retrieved it. The patient was noted as to be hospitalized in stable condition after the procedure. As per theatre staff opinion, the device has gone through at least 150 sterilization cycles. The device was available for return and evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-02846 |
| MDR Report Key | 7691606 |
| Date Received | 2018-07-16 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-06-21 |
| Date Mfgr Received | 2018-08-15 |
| Date Added to Maude | 2018-07-16 |
| 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 MLE-2 |
| 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 | 0 |
| Brand Name | CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER |
| Generic Name | SIZER, HEART-VALVE |
| Product Code | DTI |
| Date Received | 2018-07-16 |
| Model Number | 116123MM |
| Lot Number | 47378 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2018-07-16 |