BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3484920 · Received November 22, 2013

    Report

    Report Number
    2024168-2013-07606
    Event Type
    Death
    Date Received
    November 22, 2013
    Date of Event
    November 5, 2013
    Report Date
    November 5, 2013
    Manufacturer
    AV-VR-MENLO-PARK
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER, STABILIZER, LIFT, SUPPORT PLATE, MITRACLIP SYSTEM CLIP DELIVERY SYSTEM. THE MITRACLIP REMAINS IN THE ANATOMY. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL, RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, AN ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. THERE WAS NO REPORTED DEVICE MALFUNCTION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF HYPOTENSION, CARDIAC ARREST, WORSENING HEART FAILURE, RESPIRATORY FAILURE AND DEATH, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THEIR RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, A PATIENT WITH A HISTORY OF PRIMITIVE DILATATIVE CARDIOMYOPATHY UNDERWENT A MITRACLIP PROCEDURE. TWO CLIPS WERE IMPLANTED WITH GOOD RESULTS REDUCING THE PATIENT'S FUNCTIONAL MITRAL REGURGITATION GRADE FROM 4+ TO 1-2+. THE PROCEDURE DEVICE TIME WAS 94 MINUTES AND THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA FOR 2 HOURS AND 40 MINUTES. THE PROCEDURE WAS NOT COMPLICATED. AT THE END OF THE PROCEDURE, WHILE IN THE CATHETER LAB, THE PATIENT WAS EXTUBATED. SUBSEQUENTLY, THE PATIENT WENT INTO RESPIRATORY ARREST FOLLOWED BY CARDIAC ARREST. THE PATIENT WAS INTUBATED. CARDIAC MASSAGE WAS PERFORMED FOR ONE HOUR WITH MULTIPLE DISCHARGES OF THE PREVIOUSLY IMPLANTED CARDIOVERTER-DEFIBRILLATOR (ICD) AND AN EXTERNAL ICD. DUE TO LOW BLOOD PRESSURE, ADRENALIN BOLUS AND INFUSION WAS ADMINISTERED. AN INTRA-AORTIC BALLOON PUMP WAS INSERTED AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WITH A SYSTOLIC BLOOD PRESSURE OF 80-90MMHG. THE PATIENT WAS RELATIVELY STABLE. DURING THE NIGHT, DUE TO WORSENING HEART FAILURE, LEVOSIMENDAN WAS ADMINISTERED. THE PATIENT EXPIRED THE NEXT MORNING ON (B)(6) 2013 AT 6:30AM FOLLOWING WORSENING HEMODYNAMIC CONDITIONS EVEN THOUGH ALL RESUSCITATING MANEUVERS HAD BEEN PERFORMED AS PER STANDARD PROTOCOL. THE CAUSE OF DEATH WAS RESPIRATORY ARREST FOLLOWED BY CARDIAC ARREST. PER THE CLINICAL FILE, THE CAUSAL RELATIONSHIP OF THE MITRACLIP IMPLANT AND PATIENT DEATH WAS EXCLUDED (THE PROCEDURE OF MITRAL INSUFFICIENCY CORRECTION WITH MITRACLIP BY ITSELF WAS TERMINATED WITHOUT ANY PROBLEM, WITH COMPLETE EFFICACY, MR RESIDUAL 1-2+). IN THE OPINION OF THE TREATING PHYSICIAN, THE MITRACLIP PROCEDURE CONTRIBUTED TO THE RESPIRATORY AND CARDIAC ARREST AND CONTRIBUTED TO THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH, ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS AFFECTED BY PRIMITIVE DILATATIVE CARDIOMYOPATHY. THE MITRACLIP PROCEDURE WAS NOT COMPLICATED AND THE TWO IMPLANTED CLIPS HAD GOOD RESULTS WITH AN IMPORTANT REDUCTION OF THE MITRAL INSUFFICIENCY GRADE FROM 4+ TO 1-2+. THE PATIENT EXPIRED FOLLOWING WORSENING OF THE HEMODYNAMIC CONDITIONS EVEN THOUGH ALL RESUSCITATING MANEUVERS HAD BEEN PERFORMED AS PER STANDARD PROTOCOL. IN THE CLINICAL FILE, AT THE MEDICAL DIRECTION, THE CAUSAL RELATIONSHIP BETWEEN THE MITRACLIP IMPLANT AND THE PATIENT'S DEATH WAS EXCLUDED. IN THE OPINION OF THE TREATING PHYSICIAN, THE MITRACLIP PROCEDURE OR DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE HEART FAILURE. THE WORSENING HEART FAILURE WAS SECONDARY TO THE UNDERLYING POOR CONDITION OF THE LEFT VENTRICLE WHICH WAS EXACERBATED BY THE CARDIAC ARREST AND SUBSEQUENT RESUSCITATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608283 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-VR-MENLO-PARK 10276675

    Patients

    Seq Age Sex Outcome Treatment
    1 Death