BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE

    MDR report key: 3639878 · Received February 21, 2014

    Report

    Report Number
    2025587-2014-00061
    Event Type
    Death
    Date Received
    February 21, 2014
    Date of Event
    January 30, 2014
    Report Date
    March 19, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 DATE OF DEATH WAS CONFIRMED TO BE (B)(6) 2014. CORRECTED THE COMMON DEVICE NAME: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED CORRECTED THE MANUFACTURER NAME: MEDTRONIC HEART VALVES DIVISION MEDTRONIC, INC.

    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. POTENTIAL FACTORS THAT CAN INFLUENCE A DISLODGE INCLUDE TENSION APPLIED ON THE DCS DURING POSITIONING, CALCIFICATION LEVELS IN THE NATIVE VESSEL, COMPLIANCE OF THE AORTA AND NATIVE VESSELS, AND A NUMBER OF OTHERS, BUT A ROOT CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE SEVERE REGURGITATION WAS LIKELY SECONDARY TO THE DISLODGMENT. FROM THE AVAILABLE INFORMATION A CONCLUSIVE CAUSE FOR THE FRAME LOOP RELEASE DIFFICULTY COULD NOT BE DETERMINED. POTENTIAL FACTORS INFLUENCING THE DIFFICULTY INCLUDE ORIENTATION OF THE DCS TAB/FRAME LOOP AGAINST THE PATIENT¿S ANATOMY AND THE ANGLE OF DEPLOYMENT IN WHICH THE DCS TAB IS ROTATED IN THE FRAME LOOP. THIS ISSUE IS A KNOWN POTENTIAL RISK OF THE COREVALVE SYSTEM AND THE IFU PROVIDES GUIDANCE IN RELEASING THE FRAME LOOP FROM THE DELIVERY SYSTEM. IT WAS NOTED THAT THE LOOP RELEASED AFTER 10-15 SECONDS WITHOUT AN IMPACT TO THE PATIENT. THE SEVERE PVL WAS NOTED AS DUE TO PRE-EXISTING CALCIFICATION OF THE ANNULUS. AT THIS POINT, NO MITIGATING PROCEDURES WERE PERFORMED. ANEMIA, OFTEN CAUSED BY BLEEDING, IS A KNOWN POTENTIAL ADVERSE EFFECT THAT CAN OCCUR DURING THE IMPLANT PROCEDURE, WITH A VARYING RISK THAT IS DEPENDENT ON SEVERAL FACTORS SUCH AS THE ACCESS POINT FOR THE IMPLANT, THE PATIENT'S STATE OF HEALTH, AND PRE-EXISTING MEDICAL CONDITIONS. THE ISSUE IS COMMONLY RESOLVED THROUGH A BLOOD TRANSFUSION OR PROVISION OF PRBCS. THE REPORT OF PATIENT DEATH AT AN UNKNOWN NUMBER OF DAYS POST-IMPLANT WAS ASCERTAINED AS UNRELATED TO DEVICE PERFORMANCE. THE EXPIRATION WAS LIKELY RELATED TO PATIENT CONDITION AS THE PATIENT WAS NOTED AS EXTREME RISK. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT DEVICE FAILURE OR MALFUNCTION LED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CAUSE OF THE PATIENT'S DEATH WERE UNSUCCESSFUL (DATE PROVIDED IS AN ESTIMATE). THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. 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. (B)(6). (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THE PATIENT'S DEATH WAS NOT RELATED TO THE PERFORMANCE OF THE DEVICE. IT WAS ALSO REPORTED THAT POST IMPLANT THE PATIENT'S HEMAGLOBIN AND HEMATOCRIT LEVELS DECREASED TO 9.9 AND 29.2. THE PATIENT RECEIVED BLOOD TANSFUSIONS AND THE DECREASED HEMAGLOBIN AND HEMATOCRIT WERE STILL ONGOING WHEN THE PATIENT EXPIRED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WAS PERFORMED ON THIS EXTREME RISK PATIENT WHO WAS CONFIRMED BY TWO PHYSICIANS NOT TO BE A CANDIDATE FOR SURGICAL VALVE REPAIR. DURING DEPLOYMENT OF THE FIRST TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE DISLODGED AND SEVERE AORTIC REGURGITATION (AR) WAS NOTED. THE VALVE WAS SNARED AND MOVED INTO THE ASCENDING AORTA. A SECOND VALVE WAS DEPLOYED WITH DIFFICULTY DEPLOYING DUE TO THE DELIVERY CATHETER SYSTEM (DCS) FIRST TAB WAS CAUGHT AND WOULD NOT RELEASE THE VALVE LOOP (TOOK 10-15 SECONDS TO RELEASE). AFTER DEPLOYMENT, A SEVERE PARAVALVULAR LEAK (PVL) WAS NOTED DUE TO CALCIFICATION OF THE AORTIC ANNULUS. THE PVL DID NOT RESOLVE AND NO ADDITIONAL PROCEDURES WERE PERFORMED. THE PATIENT SUBSEQUENTLY EXPIRED DAYS LATER (NUMBER UNKNOWN) AND THE OFFICIAL CAUSE OF DEATH WAS NOT REPORTED. NO PRODUCTS WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110722 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-640

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death| R