BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE 23MM AORTIC VALVE

    MDR report key: 4600435 · Received March 13, 2015

    Report

    Report Number
    2025587-2015-00316
    Event Type
    Death
    Date Received
    March 13, 2015
    Date of Event
    July 29, 2014
    Report Date
    July 10, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION:WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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. THE REPORTED CLINICAL OBSERVATION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. HYPOTENSION IS A KNOWN POTENTIAL ADVERSE EFFECT PER COREVALVE INSTRUCTIONS FOR USE (IFU). IT IS AN EFFECT THAT IS HIGHLY DEPENDENT ON THE PATIENT'S PRE-PROCEDURAL CONDITION AND CAN OCCUR DESPITE A NORMALLY-FUNCTIONING DEVICE OR MODEL IMPLANT PROCEDURE. IN THIS EVENT IT WAS REPORTED TO BE DUE TO THE VENTRICULAR SEPTAL DEFECT AND NOT THE VALVE. AS NEITHER AN AUTOPSY NOR AN EXPLANT WAS PERFORMED, A CONCLUSIVE ASSESSMENT OF THE RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE COULD NOT BE REACHED. A PROCEDURE- OR VALVE-RELATED DEATH IS AN INHERENT RISK WHEN THE PATIENT CONDITION IS SUCH THAT A PERCUTANEOUS AORTIC VALVE (PAV) IS NEEDED TO SUSTAIN CARDIAC FUNCTION, AND IT CAN OCCUR DESPITE AN IDEAL IMPLANT PROCEDURE OR DEVICE FUNCTIONALITY. NO ALLEGATIONS WERE MADE AGAINST THE DEVICE, AND THERE WAS NO INDICATION THAT A MALFUNCTION OR MISUSE CONTRIBUTED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE THE PATIENT BECAME HYPOTENSIVE AND HAD DECREASED NEUROLOGIC RESPONSIVENESS. VASSOPRESSORS AND CARDIOPULMONARY RESUSCITATION (CPR) WERE PRESCRIBED. A VENTRICULAR SEPTAL DEFECT WAS IDENTIFIED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE DEFECT WAS NOT REPAIRED. THE PATIENT REMAINED INTUBATED AND DEMONSTRATED DECORTICATE POSTURING. NEUROLOGY SPECIALISTS WERE CONSULTED. NEUROLOGICALLY, THE PATIENT WAS IMPROVING, AND WAS OPENING EYES TO VERBAL STIMULI. COMPUTED TOMOGRAPHY (CT) AND ELECTROENCEPHALOGRAPHY WERE ORDERED, BUT PATIENT WAS DEEMED TOO UNSTABLE TO HAVE TESTS COMPLETED. PATIENT EXPIRED ONE DAY POST IMPLANT. NO AUTOPSY WAS PERFORMED. CAUSE OF DEATH PER PHYSICIAN WAS CARDIOVASCULAR. THE DEATH WAS NOT RELATED TO A VALVE MALFUNCTION NOR WAS THERE ANY ALLEGATION THAT THE VALVE CONTRIBUTED TO THE PATIENT'S DEATH. PER THE PHYSICIAN, THE HYPOTENSION WAS DUE TO THE VENTRICULAR SEPTAL DEFECT (VSD) AND THE PROCEDURE, NOT THE DEVICE. THE PHYSICIAN NOTED THE CAUSE OF DEATH TO BE RELATED TO THE PROCEDURE WITH NO DEVICE RELATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175158 COREVALVE 23MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-2334

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Death