BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP

    MDR report key: 22720820 · Received August 5, 2025

    Report

    Report Number
    2135147-2025-04357
    Event Type
    Death
    Date Received
    August 5, 2025
    Date of Event
    July 11, 2025
    Report Date
    October 17, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRA
    UDI-DI
    08717648288654
    PMA / PMN Number
    K190167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED DEATH, VASCULAR DISSECTION, HYPOTENSION, TACHYCARDIA, HEMORRHAGE, SWELLING, OR CARDIAC ARREST. THE CASE DETAILS WERE REVIEWED BY AN ABBOTT DIRECTOR OF MEDICAL AFFAIRS. BASED ON AVAILABLE INFORMATION, THE REPORTED VASCULAR DISSECTION APPEARS TO BE RELATED TO PROCEDURAL CONDITIONS (DAMAGE OCCURRED DURING THE IMPLANT PROCEDURE). THE REPORTED DEATH, HYPOTENSION, TACHYCARDIA, HEMORRHAGE, SWELLING, AND CARDIAC ARREST APPEAR TO BE CASCADING EVENTS OF THE VASCULAR DISSECTION. THE REPORTED PATIENT EFFECTS OF DEATH, VASCULAR DISSECTION, HYPOTENSION, CARDIAC ARRHYTHMIAS, HEMORRHAGE, SWELLING, AND CARDIAC ARREST, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT RETURNING FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR), FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, ONE MITRACLIP WAS IMPLANTED SUCCESSFULLY. WHILE REMOVING THE STEERABLE GUIDE CATHETER(SGC), BLOOD PRESSURE DECREASED AND HEMODYNAMIC DISRUPTION WAS OBSERVED. THERE WAS A GRADUAL DECREASE IN BLOOD PRESSURE DURING THE OPERATION, AND THE BLOOD PRESSURE DROPPED POST REMOVAL OF THE SGC. PATIENT'S HEART RATE INCREASED AND HEMOGLOBIN FROM 16 TO 12 G/DL. HEMATURIA WAS CONFIRMED. BLOOD TRANSFUSION WAS ADMINISTERED BUT THE PRESSURES REMAINED LOW. VASCULAR SURGEON WAS CALLED INTO THE PROCEDURE. THERE WAS SUSPECTED VENOUS DAMAGE. THE SAME SGC WAS REINSERTED ALONG WITH A BALLOON WAS FROM THE LEFT SIDE AND BLEEDING WAS CONFIRMED FROM THE FEMORAL VEIN NEAR THE PUNCTURE SITE TO THE SITE NEAR THE ILIAC VEIN. TWO NON-ABBOTT STENTS WERE PLACED TO STOP THE BLEEDING. HOWEVER, AN INCREASE IN ABDOMINAL PRESSURE WAS OBSERVED AND PATIENT BECAME HEMODYNAMICALLY UNSTABLE. THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION FOLLOWED BY CARDIAC ARREST. PERCUTANEOUS CARDIOPULMONARY SUPPORT( PCPS) WAS PERFORMED AND ONE LITER OF BLOOD DRAINAGE WAS REMOVED. THE PATIENT RETURNED TO SINUS AFTER 20 MINUTES. AN INCISION WAS MADE IN ABDOMEN TO PERFORM FURTHER DRAINAGE. IT WAS CONFIRMED THAT THERE WAS A POSSIBILITY THAT THE VEIN WAS DAMAGED DURING SGC INSERTION, AND THAT THE RETROPERITONEUM MAY HAVE BEEN PUNCTURED BY SGC COMPRESSION, BUT THE BLEEDING SITE COULD NOT BE IDENTIFIED. IT WAS REPORTED THAT THE PATIENT DEATH OCCURRED ON (B)(6) 2025 DUE TO BLEEDING FROM PUNCTURE SITE CAUSED BY THE SGC AND PCPS COULD NOT BE ESTABLISHED. THE PRE- EXISTING CONDITION OF PATIENT MAY HAVE ALSO CONTRIBUTED TO DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR), OXYGEN, MONITOR, INFUSION(OMI) AND LOW EJECTION FRACTION (EF) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, ONE MITRACLIP WAS IMPLANTED SUCCESSFULLY. DURING STEERABLE GUIDE CATHETER(SGC) REMOVAL, BLOOD PRESSURE DECREASED AND HEMODYNAMIC DISRUPTION WAS OBSERVED. THERE WAS A GRADUAL DECREASE IN BLOOD PRESSURE DURING THE OPERATION, AND THE BLOOD PRESSURE FELL BELOW 50 AFTER REMOVAL. PATIENT¿S HEARTRATE WAS OVER 100. HEMATURIA WAS ALSO CONFIRMED AND PREPARATIONS FOR BLOOD TRANSFUSION WERE MADE. SUSPECTING VENOUS DAMAGE, THE SAME SGC WAS REINSERTED AND THE BLOOD PRESSURE REMAINED IN THE 70S. A BALLOON WAS INSERTED FROM THE LEFT SIDE AND CONTRAST WAS PERFORMED. BLEEDING WAS CONFIRMED FROM THE FEMORAL VEIN NEAR THE PUNCTURE SITE TO THE SITE NEAR THE ILIAC VEIN. A 24FR DRY SEAL(DSF2433 WAS USED AT FEMORAL SITE AND TO STOP THE BLEEDING VIABAHN (REF BXAL087901J 8MM×79MM) WAS USED. AN INCREASE IN ABDOMINAL PRESSURE WAS OBSERVED AND PATIENT BECAME HEMODYNAMICALLY UNSTABLE. VENTRICULAR FIBRILLATION WAS FOLLOWED BY CARDIAC ARREST. PERCUTANEOUS CARDIOPULMONARY SUPPORT(PCPS)WAS PERFORMED TO MAKE PATIENT HEMODYNAMICALLY STABLE. AN INCISION WAS MADE IN ABDOMEN AND DRAINAGE WAS PERFORMED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT DEATH OCCURRED ON (B)(6) 2025 DUE TO BLEEDING FROM PUNCTURE SITE CAUSED BY THE SGC. PER THE PHYSICIAN, THERE WAS SIGNIFICANT BLEEDING, AND PCPS WAS UNABLE TO BE ESTABLISHED. THE PRE- EXISTING CONDITION OF PATIENT MAY HAVE ALSO CONTRIBUTED TO DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377711 MITRACLIP CATHETER, STEERABLE DRA ABBOTT MEDICAL SGC0705 50317R2093 08717648288654

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Disability| D| R MITRACLIP