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 2010-02-22 for PERIMOUNT MITRAL BIOPROSTHESIS 1177HPSET manufactured by Edwards Lifesciences.
[19947951]
Sizing issue. No product return. This event was determined to be reportable per edwards lifesciences procedures. The event was learned through via (b) (4) survey. The device history record (dhr) review was not possible due to no lot/serial number(s) were provided. No additional information was provided, device was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[19957356]
Marketing study? It was reported via (b) (4) survey conducted by (b) (4) for edwards lifesciences, (b) (4) 2009. Note the reporter (hospital, surgeon) is anonymous. The device model number and size are unknown. The complaint was as follows; the things that i don? T like about it [(b) (4)] are that the sizers tend to underestimate the size of valve that will fit in the hole and there is asymmetry of the valve with a more flat area in the region of the anterior leaflet of the mitral valve between the trigones... The sewing annulus is not a perfect circle like most valves are... All other valves i? Ve ever put in are just a circle?. Response from physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2010-12762 |
| MDR Report Key | 1611542 |
| Report Source | 05,06,07 |
| Date Received | 2010-02-22 |
| Date of Report | 2009-11-13 |
| Date of Event | 2009-11-13 |
| Date Facility Aware | 2009-11-13 |
| Date Mfgr Received | 2009-11-13 |
| Date Added to Maude | 2010-02-22 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | PERIMOUNT MITRAL BIOPROSTHESIS |
| Generic Name | SIZER SET |
| Product Code | DTI |
| Date Received | 2010-02-22 |
| Model Number | 1177HPSET |
| 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 | 2010-02-22 |