CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS

MDR report key: 8606577 · Received May 14, 2019

Report

Report Number: 2015691-2019-01715
Event Type: Injury
Date Received: May 14, 2019
Date of Event: April 18, 2019
Report Date: April 18, 2019
Manufacturer: EDWARDS LIFESCIENCES
Product Code: DYE
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

REFERENCE CAPA-20-00141.

Additional Manufacturer Narrative · 1

MODEL #: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #2800; BRAND NAME: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS; PMA #P860057/S001. THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. ATTEMPTS TO RETRIEVE THE DEVICE AND ADDITIONAL INFORMATION ARE IN PROCESS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. BASED ON THE INFORMATION RECEIVED THE CAUSE OF THE EVENT CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS.

Description of Event or Problem · 1

EDWARDS RECEIVED INFORMATION THAT A 25MM AORTIC PERICARDIAL VALVE IMPLANTED TWELVE YEARS AND EIGHT MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
400132	CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS	REPLACEMENT HEART VALVE	DYE	EDWARDS LIFESCIENCES	2900

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Required Intervention