BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 4220022 · Received November 3, 2014

    Report

    Report Number
    2025587-2014-00826
    Event Type
    Death
    Date Received
    November 3, 2014
    Date of Event
    January 25, 2014
    Report Date
    November 17, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ARTICLE¿S AUTHOR CONTACT; TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. A SEPARATE REPORT HAS BEEN FILED REGARDING THE NON-DEATH COMPLAINTS CITED IN THE ARTICLE. THE DATE OF DEATH ENTERED FOR THIS REPORT IS THE EARLIEST DATE FROM THE FOUR REPORTS THAT MAY PREVIOUSLY BEEN SUBMITTED FOR THESE COMPLAINTS. (B)(4) PSEUDOANEURYSM FORMATION AFTER MEDTRONIC FREESTYLE PORCINE AORTIC BIOPROSTHESIS IMPLANTATION: A WORD OF CAUTION AUTHORS: BRIAN R. ENGLUM, MD; ELIZABETH N. PAVLISKO, MD; MOLLY C. MACK, BA; ASVIN M. GANAPATHI, MD; MATTHEW A. SCHECHTER, MD; JENNIFER M. HANNA, MD, MBA; AND G. CHAD HUGHES, MD. ANN THORAC SURG 2014 PRESENTED AT THE POSTER SESSION OF THE FIFTIETH ANNUAL MEETING OF THE SOCIETY OF THORACIC SURGEONS, ORLANDO, FL, JAN 25¿29, 2014. PUBLISHED: ANNALS OF THORACIC SURGERY, 2014 OCT 6. PII: S0003-4975(14)01421-0. HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2014.06.062. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE HISTORY RECORDS COULD NOT BE PERFORMED, AS THE SERIAL NUMBERS HAVE NOT BEEN PROVIDED TO MEDTRONIC TO DATE. BASED ON THE LIMITED INFORMATION RECEIVED, A ROOT CAUSE COULD NOT BE DETERMINED. PSEUDOANEURYSM IS A KNOWN FAILURE MODE AND IS ADDRESSED IN THE CURRENT DEVICE RISK MANAGEMENT FILES.

    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 FROM A JOURNAL ARTICLE EXAMINING POST-IMPLANT ANEURYSMAL DETERIORATION OF MODELS FROM THIS AORTIC ROOT BIOPROSTHESIS DEVICE FAMILY. THE ARTICLE - WHICH WAS BASED ON DATA AGGREGATED FROM INSTITUTIONAL DATA FROM THE AUTHORS¿ HEALTH CARE FACILITY, THE FDA¿S MAUDE REGISTRY DATABASE, AND THE MEDICAL LITERATURE - IDENTIFIED FOUR CASES OF PATIENT DEATHS ASSOCIATED WITH ANEURYSMAL DETERIORATION OVER A 14-YEAR TIME PERIOD. THE AGGREGATED DATA SHOWED AN AVERAGE OF 37.5 MONTHS FROM IMPLANT TO WHEN A DEVICE ANEURYSM OR PSEUDOANEURYSM WAS IDENTIFIED, OCCURRING AT A RATE OF (B)(6) OF THE REVIEWED IMPLANTS. (B)(4). THE AVERAGE AGE FOR THE AGGREGATED POPULATION WAS 59 YEARS (57 YEARS AT THE AUTHORS¿ FACILITY), WITH A MAJORITY OF MALE PATIENTS. THE REPORTED VALVE SIZES RANGED FROM 23-29 MM. THE ARTICLE REPORTED THAT A MAUDE DATABASE REVIEW FOUND FOUR PATIENT DEATHS IN REPORTED CASES OF ANEURYSMS OR PSEUDOANEURYSMS ASSOCIATED WITH PRODUCTS FROM THIS DEVICE FAMILY. A REVIEW OF MEDTRONIC¿S DATABASE FOUND THE FOLLOWING FOUR PATIENT DEATHS PREVIOUSLY REPORTED AGAINST A MODEL OF THIS DEVICE WITH REFERENCE TO EITHER AN ANEURYSM OR PSEUDOANEURYSM: 2025587-2005-00092, 2025587-2005-00061, 2025587-2010-00027 AND 2025587-2009-00106. HOWEVER, WITHOUT ADDITIONAL INFORMATION, IT COULD NOT BE CONFIRMED WHETHER THESE REPORTS WERE ASSOCIATED WITH THE FOUR DEATHS CITED IN THE ARTICLE. THE AUTHORS ALSO REPORTED THAT FOUR PATIENTS AT THEIR MEDICAL FACILITY DIED WITHIN 30 DAYS OF IMPLANT OF A PRODUCT FROM THIS DEVICE FAMILY AND THUS WERE NOT ASSOCIATED WITH POST-IMPLANT ANEURYSMAL DETERIORATION. THE ARTICLE DID NOT REPORT THE CAUSE OF DEATH FOR THOSE FOUR PATIENTS, AND IT COULD NOT BE DETERMINED IF THESE DEATHS WERE PREVIOUSLY REPORTED TO MEDTRONIC. THE ARTICLE NOTED THAT THE POTENTIAL SEQUELAE OF PSEUDOANEURYSM FORMATION CAN INCLUDE TRANSIENT ISCHEMIC ATTACK, STROKE, HEART FAILURE, CARDIOPULMONARY ARREST AND SUDDEN DEATH. IT ALSO WAS NOTED THAT SOME PATIENTS WERE ASYMPTOMATIC, WITH PSEUDOANEURYSM FORMATION FOUND DURING ROUTINE SURVEILLANCE IMAGING, AND OTHER PATIENTS PRESENTED WITH CHEST PAIN OR A TRANSIENT ISCHEMIC ATTACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703730 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Death| H| R