BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    MDR report key: 12267574 · Received August 3, 2021

    Report

    Report Number
    2024168-2021-06751
    Event Type
    Death
    Date Received
    August 3, 2021
    Date of Event
    July 19, 2021
    Report Date
    September 29, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    UDI-DI
    08717648231001
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 INFLUENCED THE REPORTED EVENTS. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED FOR THE REPORTED LOT. THE QUERY IDENTIFIED NO OTHER COMPLAINTS REPORTED FOR EXPULSION FROM THE REPORTED LOT. BASED ON THIS INFORMATION, A CAUSE FOR THE REPORTED COMPLETE CLIP DETACHMENT COULD NOT BE DETERMINED. IT IS POSSIBLE THAT PATIENT ANATOMY INFLUENCED THE REPORTED EVENT, HOWEVER, THIS CANNOT BE CONFIRMED. THE REPORTED EMBOLISM WAS RELATED TO WAS DUE TO PATIENT UNDERLYING CONDITIONS. THE REPORTED MITRAL REGURGITATION (MR) WAS DUE TO THE REPORTED EXPULSION. THE REPORTED TISSUE INJURY WAS ALSO DUE TO THE REPORTED EXPULSION AS THE CLIP EMBOLIZED IN THE RIGHT CORONARY ARTERY AND TISSUE DAMAGE WAS OBSERVED. THE REPORTED MYOCARDIAL INFARCTION WAS ALSO A RESULT OF THE REPORTED EXPULSION. THE REPORTED DEATH WAS DUE TO THE CLINICAL OUTCOMES FROM THE EMBOLIZED CLIP. THE REPORTED HOSPITALIZATION, ADDITIONAL UNEXPECTED MEDICAL INTERVENTION, REMOVAL OF A FOREIGN BODY, SURGICAL INTERVENTION WERE A RESULT OF CASE SPECIFIC CIRCUMSTANCES AS THE PATIENT WAS HOSPITALIZED AND THE EMBOLIZED CLIP WAS REMOVED WITH A SNARE, AND THE PATIENT UNDERWENT BYPASS SURGERY RESPECTIVELY. THE REPORTED PATIENT EFFECTS OF MR, MYOCARDIAL INFARCTION, DEATH, TISSUE DAMAGE AND EMBOLISM AS LISTED IN THE INSTRUCTIONS FOR USE ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THIS EVENT WAS FURTHER REVIEWED BY AN ABBOTT MEDICAL AFFAIRS DIRECTOR AND THE REVIEWER CONCLUDED THAT DEATH WAS NOT DIRECTLY RELATED TO THE DEVICE BUT THE CLIP DETACHMENT WAS THE TRIGGERING FACTOR FOR THE CASCADE OF EVENTS LEADING TO SURGICAL INTERVENTION AND SUBSEQUENT DEATH. BASED ON THE AVAILABLE INFORMATION, THERE WERE NO ISSUES IDENTIFIED WITH THE DEVICE. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    THE CLIP REMAINS IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT CLIP DETACHMENT, EMBOLISM, SURGICAL INTERVENTION, PROLONGED HOSPITALIZATION, RECURRENT MITRAL REGURGITATION, MYOCARDIAL INFARCTION, AND DEATH. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE TREAT MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ON (B)(6) 2021, ONE CLIP WAS SUCCESSFULLY IMPLANTED, REDUCING MR TO 1-2. THE PATIENT WAS DISCHARGED. THEN ON (B)(6) 2021, THE PATIENT WAS READMITTED FOR MYOCARDIAL INFARCTION AND MR INCREASED TO 2+. IMAGING REVEALED THAT THE CLIP HAD DETACHED FROM BOTH LEAFLETS AND EMBOLIZED INTO THE RIGHT CORONARY ARTERY AND TISSUE DAMAGE WAS OBSERVED. THE PHYSICIAN STATED THE CLIP MAY HAVE POSSIBLY EMBOLIZED DUE TO UNDERLYING CONDITIONS. THE EMBOLIZED CLIP WAS REMOVED WITH A SNARE. THE PATIENT ALSO UNDERWENT BYPASS SURGERY, BUT THEN LATER THAT NIGHT THE PATIENT DIED DUE TO THE CLINICAL OUTCOMES FROM THE EMBOLIZED CLIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164040 MITRACLIP G4 CLIP DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT VASCULAR CDS0701-XTW 10506R219 08717648231001

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death