FDA Adverse Event Malfunction Summary report: N

MELODY TRANSCATHER PULMONARY

MDR report key: 3931565 · Received July 14, 2014

Report

Report Number: 2025587-2014-00468
Event Type: Malfunction
Date Received: July 14, 2014
Date of Event: August 19, 2011
Report Date: August 6, 2014
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Product Code: NPV
PMA / PMN Number: H080002
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. BASED ON CLINICAL DATA AND LITERATURES, MELODY STENT FRACTURES ARE KNOWN PHENOMENON. PROMINENT MECHANICAL STRESSES ON THE OUTFLOW TRACT STENT, SUCH AS COMPRESSION BETWEEN THE ANTERIOR CHEST WALL AND HEART, APPEAR TO BE ASSOCIATED WITH AN INCREASED RISK OF STENT FRACTURE. HOWEVER, A ROOT CAUSE TO THE STENT FRACTURE COULD NOT BE DETERMINED, AS THE DEVICE REMAINS IMPLANTED.

Additional Manufacturer Narrative · 1

THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. (B)(4).

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS POST-IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, ONE PORTION OF THE STENT FRACTURED. THE VALVE REMAINS IMPLANTED AND WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
409834	MELODY TRANSCATHER PULMONARY	PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED	NPV	MEDTRONIC HEART VALVES DIVISION	PB1018

Patients

Seq	Age	Sex	Outcome	Treatment
1