BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 13874702 · Received March 24, 2022

    Report

    Report Number
    2024168-2022-03058
    Event Type
    Injury
    Date Received
    March 24, 2022
    Date of Event
    February 27, 2022
    Report Date
    April 27, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE ADDITIONAL PATIENT EFFECT OF DEATH AND MALFUNCTIONS REPORTED IN THE ARTICLE ARE CAPTURED UNDER SEPARATE MEDWATCH REPORT. DATES ESTIMATED DATES: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLE "MANAGEMENT AND OUTCOME OF FAILED PERCUTANEOUS EDGE-TO-EDGE MITRAL VALVE PLASTY: INSIGHT FROM AN INTERNATIONAL REGISTRY".

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED AS THE PART AND LOT INFORMATION REGARDING THE COMPLAINT DEVICES WAS NOT PROVIDED. REPORTEDLY, FOREIGN BODY IN PATIENT AND EMBOLISM ARE RESULTED FROM REPORTED EMBOLISM AND MITRAL REGURGITATION (MR) IS RESULTED FROM REPORTED SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). ADDITIONALLY, THE REPORTED PATIENT EFFECTS OF EMBOLISM, FOREIGN BODY IN PATIENT, AND RECURRENT MR ARE LISTED IN THE INSTRUCTION FOR USE (IFU) AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. LASTLY, THE REPORTED SURGICAL PROCEDURE, UNEXPECTED MEDICAL INTERVENTION AND HOSPITALIZATION WERE A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THIS ARTICLE SUMMARY IN WHICH THE STUDY EVALUATED THE INCIDENCE, MANAGEMENT, AND OUTCOME OF PATIENTS WHO EXPERIENCED MITRACLIP (ABBOTT VASCULAR) FAILURE SECONDARY TO LOSS OF LEAFLET INSERTION (LLI), SINGLE LEAFLET DETACHMENT (SLD), OR EMBOLIZATION. A TOTAL OF 147 CASES OF MITRACLIP FAILURE WERE DETECTED (OVERALL INCIDENCE = 3.5%), AND THESE WERE SECONDARY TO LLI [WHICH WAS CLASSIFIED AS THE CLIP STILL ATTACHED AT BOTH LEAFLETS BUT WITH A DAMAGE ON IT; THE INJURY COULD RESULT IN A TEAR, PERFORATION, OR SHAPE DISTORTION] OR SLD IN 47 (31.9%) AND 99 (67.3%) CASES, RESPECTIVELY, WHEREAS IN 1 (0.8%) CASE CLIP EMBOLIZATION WAS OBSERVED. MITRACLIP FAILURE OCCURRED IN 67 (45.5%) PATIENTS WITH FUNCTIONAL MR, IN 64 (43.5%) PATIENTS WITH DEGENERATIVE MR, AND 16 (10.8%) WITH MIXED ETIOLOGY. ALTHOUGH THE MAJORITY OF MITRACLIP FAILURES WERE DETECTED BEFORE DISCHARGE (47 INTRAPROCEDURAL AND 42 IN THE HOSPITAL), UP TO 39.5% OF CASES WERE DIAGNOSED AT FOLLOW-UP. IN TOTAL, 80 (54.4%) SUBJECTS UNDERWENT A REDO PROCEDURE, EITHER PERCUTANEOUSLY WITH MITRACLIP (N = 51, 34.7%) OR SURGICALLY (N = 36, 24.5%) INCLUDING 4 CASES OF SURGICAL CONVERSION OF THE INDEX PROCEDURE AND 7 CASES OF BAILOUT SURGERY AFTER UNSUCCESSFUL REDO MITRACLIP. AFTER A MEDIAN FOLLOW-UP OF 163 DAYS (IQR: 22-720 DAYS), 50 (43.9%) SUBJECTS PRESENTED MODERATE TO SEVERE MR, AND 43 (29.3%) PATIENTS DIED. AN UP-FRONT REDO MITRACLIP STRATEGY WAS ASSOCIATED WITH A TREND TOWARD A REDUCED RATE OF DEATH AT FOLLOW-UP VS SURGICAL OR CONSERVATIVE MANAGEMENT (P = 0.067), WHEREAS POSTPROCEDURAL ACUTE KIDNEY INJURY, AGE, AND MODERATE TO SEVERE TRICUSPID REGURGITATION WERE INDEPENDENT PREDICTORS OF DEATH. MITRACLIP FAILURE SECONDARY TO LLI AND SLD IS NOT A RARE PHENOMENON AND MAY OCCUR DURING AND ALSO BEYOND HOSPITALIZATION. REDO MITRACLIP STRATEGY DEMONSTRATES A TREND TOWARD A REDUCED RISK OF DEATH COMPARED WITH BAILOUT SURGERY AND CONSERVATIVE MANAGEMENT. A THIRD OF THOSE PATIENTS REMAINED WITH MORE THAN MODERATE MR AND HAD SUBSTANTIAL MORTALITY AT THE INTERMEDIATE-TERM FOLLOW-UP. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, MANAGEMENT AND OUTCOME OF FAILED PERCUTANEOUS EDGE-TO-EDGE MITRAL VALVE PLASTY: INSIGHT FROM AN INTERNATIONAL REGISTRY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715902 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R