FDA Adverse Event Injury Summary report: N

SEE H10

MDR report key: 4335074 · Received December 16, 2014

Report

Report Number: 2015691-2014-03010
Event Type: Injury
Date Received: December 16, 2014
Date of Event: November 18, 2014
Report Date: November 18, 2014
Manufacturer: EDWARDS LIFESCIENCES
Product Code: DYE
PMA / PMN Number: SEE H10
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THIS EVENT, OR CONFIRM THE CLINICAL OBSERVATION. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL# 6625-LP, PMA# P870077.

Description of Event or Problem · 1

EDWARDS RECEIVED INFORMATION THAT THIS MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY ONE (1) YEAR. AS REPORTED, THE REASON FOR EXPLANT WAS DUE TO STENOSIS. THE SURGEON REPORTED LARGE BLOOD CLOTS ON THE VALVE, CAUSING THE VALVE TO NOT OPEN. NO ADDITIONAL DETAILS PROVIDED.

Description of Event or Problem · 1

EDWARDS RECEIVED ADDITIONAL INFORMATION INDICATING THE IMPLANT DURATION OF THE DEVICE WAS ONE (1) YEAR, SEVEN (7) MONTHS AND WAS EXPLANTED DUE TO SEVERE STENOSIS AND MILD REGURGITATION. THIS WAS REPLACED WITH A MECHANICAL VALVE AND THE PATIENT WAS NOTED AS HAVING RECOVERED WELL AND WAS LATER DISCHARGED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
823849	SEE H10	REPLACEMENT HEART VALVE	DYE	EDWARDS LIFESCIENCES	SEE H10

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Hospitalization\| R