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 2010-03-12 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 1133 manufactured by Edwards Lifesciences.
[17019362]
Reportedly while 1133, 29mm sizer was being used to measure native annulus, plastic broke in two. No patient injury. No additional information provided. On 03/03/2010, entire 1133 set was received from sales representative. The other sizers were visually inspected upon receipt and appear to be cracked, only the reported 1133, 29mm sizer is broken. E-mail requests for additional information were made on february 13, 2010, february 22, 22010, and march 03, 2010. No information was provided to the number of times used, or sterilized. No serial number is available.
Patient Sequence No: 1, Text Type: D, B5
[17244488]
Evaluation summary: received (1) 29 mm sizer in a complete set of sizers. The cylindrical end is detached from the rod. A broken piece is detected at the rod connection. The broken piece of polysulfone is returned. The replica end is connected to the rod and end exhibits cracks at the handle rod connected to the polysulfone plastic. This event was determined to be reportable per edwards lifesciences procedures. The event was learned through via telephone call from (b) (4) sales representative. A device history record review is currently in process. Requests were made via e-mail for the device, and additional information, however, no additional information was provided, device was returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[21787895]
It was reported that patient underwent left total hip arthroplasty on (b) (6) 2008 as part of a clinical study. Subsequently, irrigation and debridement and wound vac placement procedure was performed on (b) (6) 2009 due to infection. Additionally, a wound revision and flap placement procedure was performed on (b) (6) 2009. There were no components removed during either procedure. No further information has been reported to date.
Patient Sequence No: 1, Text Type: D, B5
[21830251]
A device history record was not possible due to no lot/serial number was provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2010-12856 |
| MDR Report Key | 1630099 |
| Report Source | 05,06,07 |
| Date Received | 2010-03-12 |
| Date of Report | 2010-02-10 |
| Date of Event | 2010-02-10 |
| Date Facility Aware | 2010-02-10 |
| Date Mfgr Received | 2010-03-25 |
| Date Added to Maude | 2010-04-04 |
| 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 | 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 | 2010-03-12 |
| Returned To Mfg | 2010-03-03 |
| Model Number | 1133 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Required No Informationntervention | 2010-03-12 |