BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 4900293 · Received July 8, 2015

    Report

    Report Number
    2024168-2015-03803
    Event Type
    Death
    Date Received
    July 8, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 24, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MITRACLIP REMAINS IN THE PATIENT ANATOMY. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THEREFORE, THE ANALYSIS OF THIS COMPLAINT WILL BE AN ASSESSMENT OF THE INFORMATION PROVIDED TO ABBOTT VASCULAR AND THE MANUFACTURING RECORDS FOR THE REPORTED LOT. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. IN THIS CASE, THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE CLIP DELIVERY SYSTEM (CDS). THE REPORTED PATIENT EFFECTS OF CARDIAC ARREST, DEATH, DYSPNEA, VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION (ARRHYTHMIAS) ARE LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED VENTRICULAR FIBRILLATION AND VENTRICULAR TACHYCARDIA RESULTING IN CARDIAC ARREST AND DEATH COULD NOT BE DETERMINED, A RELATIONSHIP TO THE DEVICE CANNOT BE DETERMINED. THE EVENT WAS FURTHER REVIEWED BY AN ABBOTT VASCULAR SENIOR MEDICAL ADVISOR. THE REVIEWER NOTED THAT THERE IS NO EVIDENCE OF DEVICE ISSUE OR MALFUNCTION IN CAUSING OR CONTRIBUTING TO THE REPORTED DYSPNEA, FATIGUE, ASYSTOLE, ARRHYTHMIA AND RESUSCITATION INTERVENTION THAT WAS PERFORMED. THE DEATH WAS ALSO NOT ATTRIBUTABLE TO THE DEVICE. THERE WERE NO COMPLICATIONS THAT OCCURRED DURING THE PROCEDURE AND THE CLIPS WERE CONFIRMED TO BE ATTACHED TO BOTH LEAFLETS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THAT PATIENT DEATH THAT OCCURRED ONE DAY POST MITRACLIP PROCEDURE. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE PERFORMED ON (B)(6) 2015, TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. THREE MITRACLIPS WERE IMPLANTED WITHOUT ISSUE, AND THE MR WAS REDUCED TO 2-3. THERE WERE NO REPORTED ISSUES WITH THE MITRACLIP DEVICES. ON (B)(6) 2015, ONE DAY POST-PROCEDURE, THE PATIENT LEFT THE ICU IN STABLE CONDITION. AFTER LUNCH, THE PATIENT WAS EXPERIENCING DYSPNEA AND TIREDNESS. A SHORT TIME LATER IN THE DAY, DURING A NAP, SHE WAS FOUND WITH ASYSTOLE. REANIMATION WAS INITIATED. VENTRICULAR FIBRILLATION AND VENTRICULAR TACHYCARDIA WERE OBSERVED. A PERICARDIAL EFFUSION WAS EXCLUDED AND THE IMPLANTED MITRACLIPS WERE CONFIRMED TO BE IN STABLE POSITION ON THE LEAFLETS. INTERNAL AND EXTERNAL DEFIBRILLATION WAS PERFORMED, AND CATECHOLAMINES WERE GIVEN. CARDIAC MASSAGE WAS PERFORMED; HOWEVER, AFTER APPROXIMATELY AN HOUR AND A HALF, REANIMATION WAS STOPPED AND THE PATIENT DIED. IN THE PHYSICIANS OPINION, THE CAUSE OF DEATH MAY HAVE BEEN AN ELECTROPHYSIOLOGY ISSUE. AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443679 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 50122U108

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death IMPLANTED MITRACLIPS (X2)