BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 6125499 · Received November 23, 2016

    Report

    Report Number
    2024168-2016-08320
    Event Type
    Death
    Date Received
    November 23, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 23, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    UDI-DI
    08717648195914
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: MITRACLIP SYSTEM, STEERABLE GUIDE CATHETER, 1 ADDITIONAL IMPLANTED MITRACLIP. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS REPORTED FROM THIS LOT. THIS EVENT WAS FURTHER REVIEWED BY AN ABBOTT VASCULAR SENIOR MEDICAL ADVISOR. THE REVIEWER NOTED THAT THE PROCEDURE WAS PERFORMED IN UNSTABLE CONDITIONS. THE REVIEWER CONTINUED THAT THE PATIENT INSTABILITY CONTINUED POST PROCEDURE UNTIL FATAL OUTCOME AND DEATH WAS DUE TO WORSENING OF PRE-EXISTING CONDITION AND NOT RELATED TO THE DEVICE. ALL AVAILABLE INFORMATION WAS INVESTIGATED AND THE REPORTED SLDA APPEARS TO BE RELATED TO CHALLENGING PATIENT MORPHOLOGY/PATHOLOGY DUE TO THE PRE-EXISTING LEAFLET FLAIL. THE REPORTED PATIENT DEATH WAS LIKELY A RESULT OF THE PATIENTS CONDITION AND DUE TO PRE-EXISTING COMORBIDITIES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURING OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    THIS IS CONSERVATIVELY FILED FOR THE PATIENT DEATH AND THE SINGLE LEAFLET DEVICE ATTACHMENT. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. THE PATIENT PRESENTED IN POOR CONDITION, AND WAS NOT STABLE. ONE CLIP WAS IMPLANTED, REDUCING THE MR TO 3. THE SECOND CLIP DELIVERY SYSTEM (CDS 60203U133) WAS ADVANCED TO THE MITRAL VALVE, AND GRASPING WAS PERFORMED. LEAFLET INSERTION WAS CONFIRMED AND THE CLIP WAS DEPLOYED; HOWEVER, MR REMAINED AT 3. AFTER DEPLOYMENT, THE CLIP DETACHED FROM ONE LEAFLET AND REMAINED ATTACHED TO THE OTHER LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THE MR REMAINED AT 3. IT WAS THOUGHT THAT THE SLDA OCCURRED DUE TO THE PRE-EXISTING FLAIL. A THIRD CDS (60805U117) WAS ADVANCED FOR STABILIZATION OF THE SLDA CLIP. GRASPING WAS ATTEMPTED, BUT WAS NOT SUCCESSFUL BECAUSE THE TRANSSEPTAL WAS NOT FAVORABLE FOR MEDIAL PLACEMENT OF THE CLIP, AND THE VISIBILITY WAS POOR. THE CDS WAS REMOVED AND THE CLIP WAS NOT DEPLOYED. TWO CLIPS WERE IMPLANTED, REDUCING MR TO 3. THE FOLLOWING DAY, THE PATIENT DIED. ALTHOUGH THE CAUSE OF DEATH WAS UNKNOWN, THE PHYSICIAN STATED IT WAS DUE TO PRE-EXISTING CONDITIONS; HOWEVER, AFTER THE MITRACLIP PROCEDURE, THE PATIENT BECAME MORE UNSTABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777063 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 60203U133 08717648195914

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death