BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRICLIP DELIVERY SYSTEM (TCDS)

    MDR report key: 19510806 · Received June 11, 2024

    Report

    Report Number
    2135147-2024-02716
    Event Type
    Death
    Date Received
    June 11, 2024
    Date of Event
    December 31, 2022
    Report Date
    June 24, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED THE ADDITIONAL PATIENT EFFECTS AND MALFUNCTIONS REPORTED IN THE ARTICLES ARE CAPTURED UNDER SEPARATE MEDWATCH REPORTS. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    A2: MEAN AGE. A3: MAJORITY GENDER. B2: DATE OF DEATH WAS ESTIMATED. B3: DATE OF EVENT WAS ESTIMATED. D4: THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED D6A: DATE OF IMPLANT WAS ESTIMATED. THE ADDITIONAL PATIENT EFFECTS AND MALFUNCTIONS REPORTED IN THE ARTICLES ARE CAPTURED UNDER SEPARATE MEDWATCH REPORTS. LITERATURE ATTACHMENT: ARTICLE E-225088: "COMPUTED TOMOGRAPHY ANATOMIC PREDICTORS OF OUTCOMES IN PATIENTS UNDERGOING TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR" THE DEVICES WERE NOT RETURNED FOR ANALYSIS AS THIS COMPLAINT IS BASED ON AN ARTICLE REVIEW. A REVIEW OF THE LOT HISTORY RECORD AND A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED AS THIS COMPLAINT IS BASED ON AN ARTICLE REVIEW, AND LOT/DEVICE INFORMATION IS NOT AVAILABLE. BASED ON AVAILABLE INFORMATION, CAUSES FOR THE POSITIONING FAILURE, DIFFICULT OR DELAYED POSITIONING, AND INCOMPLETE COAPTATION COULD NOT BE DETERMINED. CAUSES FOR THE REPORTED DEATH, HEART FAILURE, AND TRICUSPID REGURGITATION COULD NOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF DEATH, HEART FAILURE, AND TRICUSPID REGURGITATION AS LISTED IN THE TRICLIP INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH TRICLIP PROCEDURES. THE REPORTED UNEXPECTED MEDICAL INTERVENTION AND HOSPITALIZATION WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THE ARTICLE " COMPUTED TOMOGRAPHY ANATOMIC PREDICTORS OF OUTCOMES IN PATIENTS UNDERGOING TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, OBSERVATIONAL, AND SINGLE-CENTER STUDY, AIMED TO IDENTIFY ANATOMICAL COMPUTED TOMOGRAPHY (CT) PREDICTORS OF PROCEDURAL AND CLINICAL OUTCOMES IN PATIENTS UNDERGOING TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR (T-TEER). DEVICES MENTIONED INCLUDE THE MITRACLIP AND TRICLIP. THE ARTICLE CONCLUDED THAT CT-DERIVED RIGHT VENTRICULAR (RV) LENGTH AND INFERIOR VENA CAVA (IVC) AND TRICUSPID ANNULUS (TA) HEIGHT MAY BE HELPFUL TO IDENTIFY PATIENTS AT INCREASED RISK FOR PROCEDURAL COMPLEXITY AND ADVERSE OUTCOMES WHEN UNDERGOING T-TEER. CT PROVIDES VALUABLE INFORMATION FOR PREPROCEDURAL DECISION-MAKING AND DEVICE SELECTION. [THE PRIMARY AUTHOR WAS JOANNA BARTKOWIAK, DEPARTMENT OF MEDICINE, THE NEWYORK PRESBYTERIAN/COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEW YORK, NY, USA. THE CORRESPONDING AUTHOR WAS: FABIEN PRAZ, DEPARTMENT OF CARDIOLOGY, UNIVERSITY OF BERN, INSELSPITAL, BERN, SWITZERLAND, WITH CORRESPONDING EMAIL : [email protected]]. THE TIME FRAME OF THE STUDY WAS BETWEEN MARCH 2018 AND DECEMBER 2022. A TOTAL OF 33 PATIENTS WERE INCLUDED IN THIS STUDY OF WHICH ALL RECEIVED EITHER A TRICLIP, MITRACLIP OR NON-ABBOTT DEVICE. THE AVERAGE AGE OF THE PATIENTS ENROLLED WAS 80. THE MAJORITY GENDER WAS MALE. AS THIS IS FROM A LITERATURE REVIEW, PATIENT WEIGHT WAS NOT PROVIDED. COMORBIDITIES INCLUDED: PREVIOUS MI, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, CORONARY ARTERY BYPASS GRAFTING, HEART FAILURE, MYOCARDIAL INFARCTION, MITRAL REGURGITATION, PACEMAKER, TRICUSPID REGURGITATION (PRIMARY, VENTRICULAR, AND ATRIAL), PNEUMOPATHY, HYPERTENSION, DIALYSIS, LIVER DISEASE, RENAL DISEASE, PULMONARY HYPERTENSION, AND PREVIOUS CARDIAC SURGERY (OTHER VALVES, TRICUSPID, OTHER). INTRA, PERI AND POST-PROCEDURAL COMPLICATIONS INCLUDED SINGLE LEAFLET DEVICE ATTACHMENT (SLDA), INABILITY AND DIFFICULTY POSITIONING THE DEVICE, ALL-CAUSE MORTALITY (DEATH), HEART FAILURE, HOSPITALIZATION, TRICUSPID REGURGITATION, AND TRICUSPID RE-INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171569 TRICLIP DELIVERY SYSTEM (TCDS) TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Death