BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    MDR report key: 10268437 · Received July 13, 2020

    Report

    Report Number
    2024168-2020-05747
    Event Type
    Death
    Date Received
    July 13, 2020
    Date of Event
    June 23, 2020
    Report Date
    August 25, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    UDI-DI
    08717648230943
    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 CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO PRODUCT ISSUE REPORTED FROM THIS LOT. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF DEATH, EMBOLISM, HEART FAILURE, HYPERTENSION, CARDIOGENIC SHOCK, TACHYCARDIA, FOREIGN BODY IN PATIENT AND TISSUE DAMAGE ARE LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THIS EVENT WAS FURTHER REVIEWED BY AN ABBOTT MEDIAL AFFAIRS DIRECTOR. THE REVIEWER CONCLUDED THE DEATH WAS UNRELATED TO THE DEVICE BUT THE CLIP DETACHMENT WAS THE TRIGGERING FACTOR FOR THE CASCADE OF EVENTS. PROVIDED IMAGES WERE REVIEWED BY THE MEDICAL AFFAIRS TEAM AND THE REVIEWER STATED THAT THE 1ST CLIP SEEMS TO BE NOT VERY STABLE ALREADY BEFORE THE FULL SLDA HAPPENED. MULTIPLE GRASPING ATTEMPTS HAVE BEEN DONE WITH THE 2ND CLIP AND IN THE END THE 2ND CLIP DETACHED FROM THE POSTERIOR LEAFLET. IT¿S NOT POSSIBLE TO UNDERSTAND FROM THE PROVIDED IMAGES IF THE 2ND CLIP TORE SOME CHORDAE DURING THE MULTIPLE GRASPING ATTEMPTS CAUSING THE SLDA OR IF THE 2ND CLIP INTERACTED WITH THE 1ST CLIP AND DETACHED THE 1ST CLIP FROM THE POSTERIOR LEAFLET, CREATING SMALL RUPTURED CHORDAE. AT THE END OF THE PROCEDURE, THE 1ST CLIP WAS NOT STABILIZED BY THE IMPLANTATION OF THE 2ND CLIP. MISSING THE BASAL ECHO IMAGES AND THE 1ST CLIP IMPLANTATION IMAGES, IT¿S NOT POSSIBLE TO MAKE COMPARISONS. ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED DEVICE DAMAGED BY ANOTHER DEVICE-DISLODGED APPEARS TO BE RELATED TO USER TECHNIQUE/PROCEDURAL CIRCUMSTANCES. THE REPORTED SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) APPEARS TO BE DUE TO PROCEDURAL CONDITION. ADDITIONALLY, THE REPORTED EXPULSION/COMPLETE CLIP DETACHMENT RESULTING IN FOREIGN BODY IN PATIENT AND EMBOLISM APPEARS TO BE DUE TO PROCEDURAL CIRCUMSTANCES. A DEFINITIVE CAUSE FOR THE REPORTED HYPERTENSION, TACHYCARDIA AND CARDIAC SHOCK COULD NOT BE DETERMINED. THE REPORTED HEART FAILURE WAS DUE TO THE SURGERY AND PULMONARY HYPERTENSION. THE REPORTED DEATH WAS DUE TO RIGHT HEART FAILURE. THE REPORTED TISSUE DAMAGE APPEARS TO BE DUE TO PROCEDURAL CIRCUMSTANCES. THERE IS NO INDICATION OF PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: BASED ON IMAGE REVIEW, A SMALL RUPTURED CHORDAE, WAS CAUSED BY CLIP 00122U130.

    Additional Manufacturer Narrative · 1

    THE CLIP REMAINS EMBOLIZED IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER MITRACLIP REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT THE PATIENT DEATH. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE PERFORMED TO TREAT GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR). THE FIRST CLIP (00122U130) WAS IMPLANTED WITHOUT ISSUE. TO FURTHER REDUCE MR, A SECOND CLIP WAS ADVANCED TO THE MITRAL VALVE (00121U114). THE SECOND CLIP INTERACTED WITH THE FIRST IMPLANTED CLIP; CAUSING THE CLIP TO DETACH FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SLDA). THE SECOND CLIP WAS IMPLANTED SLIGHTLY STABILIZING THE SLDA CLIP; HOWEVER, MR REMAINED AT 4. ON (B)(6) 2020, THE PATIENT WAS SENT TO SURGERY (MITRAL VALVE REPLACEMENT) AS THE SLDA CLIP HAD COMPLETELY DETACHED FROM THE LEAFLETS AND EMBOLIZED. IT WAS NOTED THE SECOND CLIP HAD ALSO DETACHED FROM THE POSTERIOR LEAFLET, AND WAS REMOVED DURING THE SURGERY. THE EMBOLIZED CLIP WAS NOT RETRIEVED AND REMAINED IN THE PATIENT. ON (B)(6) 2020 THE PATIENT PASSED AWAY DUE TO RIGHT HEART FAILURE, CARDIOGENIC SHOCK AND VENTRICULAR TACHYCARDIA. THE PHYSICIAN STATED THE RIGHT HEART FAILURE WAS DUE TO THE SURGERY AND PULMONARY HYPERTENSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729975 MITRACLIP G4 CLIP DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT VASCULAR CDS0701-NT 00122U130 08717648230943

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death STEERABLE GUIDE CATHETER.