MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number T510

Device Problems Perivalvular Leak (1457); Structural Problem (2506)

Patient Problems Endocarditis (1834); Blood Loss (2597); Thromboembolism (2654)

Event Date 12/20/2015

Event Type  Injury  

Manufacturer Narrative

Title: mid- to long-term clinical outcomes of hancock ii bioprosthesis in chinese population citation: chinese medical journal 2015 volume 128(24):3317-23 (doi 10.4103/0366-6999.171424) authors: yin wang, si chen, xing-jian hu, jia-wei shi, nian-guo dong.Date of publish was used for incident date.No unique device identifier (serial/lot) numbers were provided; without this information, it cannot be determined whether this event has been previously reported.

Event Description

Medtronic received information via literature review regarding the mid- to long-term clinical performance of hancock ii bioprosthesis in the chinese population.All data were collected retrospectively from a single center between january 2004 and december 2013.The study population included 647 patients (predominantly male; average age 61.9 ± 18.3 years), all of which were implanted with medtronic hancock aortic (avr) (n=262) mitral (mvr) (n=311) or both aortic and mitral (dvr) ( n=74) valve.Serial numbers were not provided.Among all patients adverse events included: 21 incidents of bleeding that required a blood transfusion (6 avr, 12 mvr and 3 dvr).Twenty six incidents of thromboembolism occurred (9 avr, 13 mvr, and 4 dvr).Eight incidents of endocarditis (4 avr, 3 mvr and 1 dvr), 6 of which were treated with surgical intervention and 2 treated medically.Twelve incidents of structural valve deterioration occurred (svd) (4 avr, 6 mvr, 2 dvr) all incidents of svd were treated with reoperation.Other adverse events included: 11 incidents of paravalvular leak (pvl), (6 avr, 4 mvr, and 1 dvr).Eight of these incidents were severe and required reoperation.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5807246
• MDR Text Key: 49943387
• Report Number: 2025587-2016-01099
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T510
• Device Catalogue Number: T510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR