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

Model Number T505

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 of event no unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

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 + or - 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 AORTIC 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: 5807301
• MDR Text Key: 49944576
• Report Number: 2025587-2016-01100
• 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: T505
• Device Catalogue Number: T505
• 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