BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

    MDR report key: 7769089 · Received August 9, 2018

    Report

    Report Number
    2024168-2018-06142
    Event Type
    Death
    Date Received
    August 9, 2018
    Date of Event
    July 18, 2018
    Report Date
    October 23, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DRA
    PMA / PMN Number
    K161985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF DEATH, HEMORRHAGE, WEAKNESS, COAGULOPATHY AND CARDIAC ARREST, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. BASED ON THE INFORMATION REVIEWED, THE REPORTED WEAKNESS WAS DUE TO THE HEMORRHAGE AND THE HEMORRHAGE APPEARS TO BE RELATED TO PROCEDURAL CONDITIONS. THE REPORTED CARDIAC ARREST AND SUBSEQUENT DEATH WAS DUE TO DISSEMINATED VASCULAR COAGULATION (DIC). HOWEVER, A DEFINITIVE CAUSE FOR THE DIC (COAGULOPATHY) CANNOT BE DETERMINED AS THE ACCOUNT REPORTER IS NOT WILLING TO DISCUSS THE EVENT ANY FURTHER. IT IS POSSIBLE THAT THE PATIENTS FRAIL CONDITION CONTRIBUTED TO THE COAGULOPATHY; HOWEVER, THIS CANNOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    THIS REPORT IS FILED DUE FOR POST PROCEDURE FEMORAL VEIN BLEED, HEMATOMA, DISSEMINATED VASCULAR COAGULATION (DIC), AND DEATH. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED. ONE MITRACLIP WAS IMPLANTED IN THE PATIENT WITH DEGENERATIVE MITRAL REGURGITATION (MR) GRADE 4, REDUCING THE MR TO GRADE 2. THERE WERE NO DEVICE ISSUES. POST-PROCEDURE, A FEMORAL VENOUS ACCESS SITE BLEED WAS NOTED. THE PATIENT WAS TOO WEAK FOR SURGERY; HOWEVER, THE BLEEDING WAS CONTROLLED WITH A FEMOSTOP DEVICE. THE FEMOSTOP DEVICE STOPPED THE EXTERNAL BLEEDING. A COMPUTERIZED TOMOGRAPHY SCAN WAS PERFORMED AND A HEMATOMA WAS NOTED AT THE ACCESS SITE. POST-PROCEDURE, THE PATIENT WENT INTO DISSEMINATED VASCULAR COAGULATION (DIC). ON (B)(6) 2018, THE PATIENT HAD CARDIOPULMONARY ARREST AND EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611430 MITRACLIP SYSTEM STEERABLE GUIDE CATHETER STEERABLE GUIDE CATHETER DRA AV-TEMECULA-CT 80410U134

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death 1 IMPLANTED MITRACLIP