MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-09-04 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 1133 manufactured by Edwards Lifesciences.
[25048131]
Additional manufacturer narrative: the sizer is anticipated for return to edwards lifesciences and an evaluation of the product is currently pending its arrival. A supplemental report will be submitted upon completion.
Patient Sequence No: 1, Text Type: N, H10
[25048132]
Edwards received information that during an aortic valve replacement procedure, a valve sizer broke while the surgeon was introducing the sizer into the patient's annulus. There were no reported complications for the patient as a result.
Patient Sequence No: 1, Text Type: D, B5
[31631734]
Method: actual device not evaluated. Additional manufacturer narrative - although there have been attempts to retrieve the broken sizer, the product was not returned to edwards lifesciences for analysis as the hospital believes they discarded it. No additional information was provided by the hospital or surgeon to suggest that a serious injury occurred to the patient as a result of the fracture. 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
| Report Number | 2015691-2015-02317 |
| MDR Report Key | 5057175 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-09-04 |
| Date of Report | 2015-08-13 |
| Date of Event | 2015-08-13 |
| Date Mfgr Received | 2015-08-13 |
| Date Added to Maude | 2015-09-04 |
| 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: 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 | 2015-09-04 |
| Model Number | 1133 |
| 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 | 2015-09-04 |