MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2009-05-07 for CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING 4450M manufactured by Edwards Lifesciences.
[1158051]
Reportedly, the device (ring) was explanted and replaced with a valve (6900p29mm). No further details were provided. The device was discarded and will not be returned for evaluation. Information learned through foreign implant patient registry. It is suggested that this was a failed ring repair. However, no information is available. The device history record (dhr) review is in process. No other information is available..
Patient Sequence No: 1, Text Type: D, B5
[8431948]
Information learned from the implantation data card completed by the hospital or staff and returned to the foreign implant patient registry. It is suggested that this was a failed ring repair but is not confirmed. No other information is available. The device history record (dhr) review is completed and this device passed all manufacturing and sterilization inspections with no nonconformance. This was determined to be reportable per edwards lifesciences procedures.
Patient Sequence No: 1, Text Type: N, H10
[8460842]
X-ray.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2009-10491 |
| MDR Report Key | 1375025 |
| Report Source | 01,06,07 |
| Date Received | 2009-05-07 |
| Date of Report | 2009-04-06 |
| Date of Event | 2009-03-23 |
| Date Facility Aware | 2009-03-23 |
| Date Mfgr Received | 2009-04-06 |
| Device Manufacturer Date | 2009-02-06 |
| Date Added to Maude | 2009-07-03 |
| 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 | 3 |
| 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 PHYSIO ANNULOPLASTY RING |
| Generic Name | ANNULOPLASTY RING |
| Product Code | DTI |
| Date Received | 2009-05-07 |
| Model Number | 4450M |
| Lot Number | 09A029 |
| Device Expiration Date | 2014-01-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 MO |
| 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 | 2009-05-07 |