CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ MITRAL PERICARDIAL BIOPROSTHESIS

Report

Report Number: 2015691-2010-14203
Event Type: Injury
Date Received: October 15, 2010
Date of Event: September 20, 2010
Report Date: September 20, 2010
Manufacturer: EDWARDS LIFESCIENCES
Product Code: DYE
PMA / PMN Number: P860057/S029
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY:CHARACTERISTIC MARKINGS ON THE VALVE INDICATE A SUTURE WAS LOOPED AROUND COMMISSURE 1. SUTURE TRACK AND PERMANENT INDENTATIONS WERE PRESENT ON THE FREE MARGIN AND CUSP OF LEAFLETS 1 AND 3. THESE INDENTATIONS WERE MOST LIKELY LEFT BY A SUTURE THAT WAS TIED TIGHTLY DOWN AND AGAINST THE POSTS AT THE CUSP 1 COMMISSURE. AS RECEIVED A GAP IS NOTED AT THE COAPTATION REGION. NO VISIBLE INCONSISTENCIES WERE NOTED IN THE X-RAY.THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

Description of Event or Problem · 1

THE FOLLOWING WAS REPORTED VIA EMAIL BY A HEALTHCARE PROVIDER FROM (B)(6) MEDICAL CENTER, "THIS IS THE INFORMATION THAT I HAVE ON THE MITRAL VALVE THAT THE SURGEON PUT IN AND REMOVED AS DEFECTIVE. IT IS A MODEL: 7000TFX 29MM. (B)(4). IT WAS REMOVED AND HAND RINSED AND I HAVE IT (AND THE ORIGINAL BOX ) IN A PLASTIC BAG IN MY OFFICE AS WELL AS THE IMPLANT PATIENT REGISTRY THAT WAS FILLED OUT. I HAVE ALREADY ORDERED A REPLACEMENT VALVE TO COME BACK OVERNIGHT. THE SURGEON REMOVED THIS VALVE AND REPLACED IT WITH A COMPETITOR VALVE." NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CARPENTIER-EDWARDS® PERIMOUNT MAGNA¿ MITRAL PERICARDIAL BIOPROSTHESIS	REPLACEMENT HEART VALVE	DYE	EDWARDS LIFESCIENCES	7000TFX	R-10A0101

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR		Required Intervention