FDA Adverse Event Summary report: N

HANCOCK II

MDR report key: 3212397 · Received June 25, 2013

Report

Report Number
3212397
Date Received
June 25, 2013
Date of Event
April 18, 2013
Report Date
June 25, 2013
Manufacturer
MEDTRONIC, INC.
Product Code
LWR
Report Source
User Facility report
Reporter Location
MT, US

Narratives

Description of Event or Problem · 1

THIS PATIENT HAD HIS BICUSPID AORTIC VALVE REPLACED WITH A 25 MM HANCOCK II BIOPROSTHETIC VALVE. OVER THE LAST SEVERAL FOLLOW UP ECHOCARDIOGRAMS, HIS VELOCITIES ACROSS THE VALVE HAVE BEEN GRADUALLY INCREASING AND APPROACHING 5 M/SEC. WITH THIS MOST RECENT STUDY APPROXIMATELY FOUR MONTHS AGO, THE VELOCITY HAD SIGNIFICANTLY DECREASED. HOWEVER, HIS AORTIC INSUFFICIENCY, WHICH HAD BEEN MILD, NOW WAS FULLY MODERATE. THE PATIENT IS ALSO BECOMING MORE SYMPTOMATIC WITH INCREASING FATIGUE AND EXERTIONAL SHORTNESS OF BREATH. THE PATIENT HAS NOT HAD ANGINAL SYMPTOMS, ORTHOPNEA, PND, OR PERIPHERAL EDEMA. ECHOCARDIOGRAM SHOWED MODERATE AORTIC REGURGITATION, SEVERE AORTIC STENOSIS BY VELOCITIES AND MILDLY ENLARGED ASCENDING AORTA. IT MEASURED 4.2 BY ECHOCARDIOGRAM AND WAS CONFIRMED BY CTA. HOWEVER, THE AORTIC ROOT AND THE DISTAL ASCENDING AORTA ARE NORMAL CALIBER. IT IS A VERY BRIEF SEGMENT THAT IS SIGNIFICANTLY ENLARGED.OPERATIVE FINDINGS: THE ASCENDING AORTA WAS DESCRIBED. THE BEGINNING ANEURYSMAL CALIBER IS IN THE MID PORTION ONLY AND TAPERS VERY QUICKLY TO 3 CM BEFORE THE TAKEOFF OF THE INNOMINATE ARTERY. THE AORTIC ROOT IS UNDILATED. THE ANNULUS MEASURED 23 MM. THE AORTIC ROOT AT THE LEVEL OF THE SINOTUBULAR JUNCTION WAS 3.5 CM.THE PROSTHETIC VALVE LEAFLETS WERE PLIABLE WITH A TEAR IN THE LEFT CORONARY CUSP NEAR THE JUNCTION WITH THE NONCORONARY SINUS. THE INCREASED VELOCITIES WERE MOST LIKELY DUE TO PANNUS INGROWTH IN THE LEFT VENTRICULAR OUTFLOW TRACT AT THE BASE OF THE VALVE SEWING RING. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BICUSPID AORTIC VALVE REPLACEMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
288640 HANCOCK II HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC, INC. HANCOCK II AORTIC VALVE 25 *

Patients

Seq Age Sex Outcome Treatment
1 58 YR NO OTHER DEVICES CONTRIBUTORY.| NO OTHER THERAPIES