BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3873111 · Received June 13, 2014

    Report

    Report Number
    2024168-2014-03833
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 21, 2014
    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. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE MITRACLIP REMAINED IMPLANTED IN THE PATIENT. THE ANALYSIS OF THIS COMPLAINT WILL BE AN ASSESSMENT OF THE MANUFACTURING RECORDS AND INFORMATION PROVIDED TO ABBOTT VASCULAR. IN THIS CASE, THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE CLIP DELIVERY SYSTEM (CDS). THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND DEATH, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED INFORMATION PROVIDED STATED THAT PER THE PHYSICIAN, THE CAUSE OF THE DEATH WAS AN OCCLUSION IN A BYPASS. THE ETIOLOGY OF OCCLUSION WAS A THROMBUS. THE PHYSICIAN STATED THAT THE OCCLUSION WAS NOT A RESULT OF THE MITRACLIP PROCEDURE OR THE THREE IMPLANTED CLIPS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE 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

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DATE OF THE BYPASS WAS (B)(6) 1992. THE PHYSICIAN DOES NOT THINK THAT THE THREE IMPLANTED CLIPS CAUSED OR CONTRIBUTED TO THE DEATH. THE DATE OF DEATH WAS (B)(6) 2014. THE AUTOPSY WAS PERFORMED ON (B)(6) 2014 AND THE CAUSE OF DEATH WAS CONFIRMED TO BE AN OCCLUSION IN A BYPASS. THE ETIOLOGY OF THE OCCLUSION WAS A THROMBUS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT IS CONSERVATIVELY FILED AS THE PATIENT EXPIRED POST PROCEDURE DUE TO AN OCCLUDED BYPASS. THE IMPLANTED CLIP CANNOT BE EXCLUDED AS POTENTIALLY CAUSING OR CONTRIBUTING TO THE OCCLUSION. IT WAS REPORTED THAT ON (B)(6) 2014, A MITRACLIP PROCEDURE WAS PERFORMED AND THREE CLIPS WERE IMPLANTED. THE PROCEDURE HAD A SUCCESSFUL OUTCOME AS THE MIXED MITRAL REGURGITATION GRADE WAS REDUCED FROM 4 TO 1-2. POST PROCEDURE, THE PATIENT WAS STABLE AND WAS SENT TO THE INTENSIVE CARE UNIT FOR FURTHER CARE AND MONITORING. DURING THE NIGHT, THE PATIENT EXPIRED DUE TO OCCLUSIONS INSIDE A BYPASS, CONFIRMED ON AUTOPSY. THE OCCLUSIONS WERE NOT OBSERVED PRIOR TO THE MITRACLIP PROCEDURE. HOWEVER, THE PHYSICIAN ASSURES THAT THE MITRACLIP PROCEDURE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349482 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 10317975

    Patients

    Seq Age Sex Outcome Treatment
    1 Death