FDA.reportPublic FDA data

MAUDE MDR 1375025

MDR report key
1375025
Report number
2015691-2009-10491
Event key
0
Event type
3
Date of event
2009-03-23
Date received
2009-05-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. NEIL LANDRY
Address
ONE EDWARDS WAY MAILSTOP: MS HVC96 IRVINE CA 92614 US
Phone
949-949-9492
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RINGANNULOPLASTY RINGEDWARDS LIFESCIENCESDTI4450M09A029R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-05-0701. R

Event Narratives#

D

Patient 1

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..

N

Patient 1

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.

N

Patient 1

X-RAY.