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 2009-08-30 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 1130 manufactured by Edwards Lifesciences.
[21611340]
Reportedly, a handle broke during a procedure in 2009. Handle was disposed of. No additional information was provided at this time. At approx 20 days later, additional information received per e-mail indicates that the device was a 1130 sizer, 23mm. Surgeon noticed the sizer was cracked when the surgeon went to size the valve. Sales representative indicates that he thinks it was due to the sterilization process.
Patient Sequence No: 1, Text Type: D, B5
[21825881]
Device not returned. This event was determined to be reportable per edwards lifesciences procedures. The event was learned through via telephone call from hvt sales representative. The device history record (dhr) review was not possible, due to no lot/serial number is available. Requests were made via e-mail for the device, operative report, and additional information, however, no additional information was provided, device was not returned for evaluation due to it was discarded by the hospital.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2009-11411 |
| MDR Report Key | 1456604 |
| Report Source | 05,06,07 |
| Date Received | 2009-08-30 |
| Date of Report | 2009-07-31 |
| Date of Event | 2009-07-30 |
| Date Facility Aware | 2009-07-30 |
| Date Mfgr Received | 2009-07-31 |
| Date Added to Maude | 2009-08-30 |
| 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 | ONE EDWARDS WAY MAILSTOP: MS HVC96 |
| 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 | 2009-08-30 |
| Model Number | 1130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2009-08-30 |