BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRICLIP DELIVERY SYSTEM (TCDS)

    MDR report key: 19235934 · Received May 3, 2024

    Report

    Report Number
    2135147-2024-01958
    Event Type
    Death
    Date Received
    May 3, 2024
    Date of Event
    January 1, 2010
    Report Date
    May 30, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2 - DATE OF DEATH IS ESTIMATED. B3 - DATE OF EVENT IS ESTIMATED. D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE ADDITIONAL PATIENT EFFECTS REPORTED IN THE ARTICLES ARE CAPTURED UNDER A SEPARATE MEDWATCH REPORT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD AND SIMILAR COMPLAINT REVIEW COULD NOT BE PERFORMED AS THE PART AND LOT NUMBER REGARDING THE COMPLAINT DEVICE WAS NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED DEATH, TR, HEART FAILURE, HEMORRHAGE, RENAL FAILURE, PERICARDIAL EFFUSION, HYPOTENSION, CEREBROVASCULAR ACCIDENT, ATRIAL FIBRILLATION, AND INFECTION. DEATH, TR, HEART FAILURE, HEMORRHAGE, RENAL FAILURE, PERICARDIAL EFFUSION, HYPOTENSION, CEREBROVASCULAR ACCIDENT, ATRIAL FIBRILLATION, AND INFECTION ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH TRICLIP PROCEDURES. THE REPORTED HOSPITALIZATION, UNEXPECTED MEDICAL INTERVENTIONS, AND SURGICAL INTERVENTION WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PATIENT EFFECTS AND MALFUNCTIONS REPORTED IN THE ARTICLE(S) ARE CAPTURED UNDER SEPARATE MEDWATCH REPORT(S). LITERATURE ATTACHMENT: ARTICLE TITLE: PREDICTION OF MORTALITY AND HEART FAILURE HOSPITALIZATION AFTER TRANSCATHETER TRICUSPID VALVE INTERVENTIONS. 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.

    Description of Event or Problem · 0

    THE ARTICLE, ¿PREDICTION OF MORTALITY AND HEART FAILURE HOSPITALIZATION AFTER TRANSCATHETER TRICUSPID VALVE INTERVENTIONS¿, WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTIPLE CENTER EXPERIENCE TO EVALUATE THE PERFORMANCE OF THE TRI-SCORE IN PREDICTING OUTCOMES OF PATIENTS UNDERGOING TRANSCATHETER TRICUSPID VALVE INTERVENTION (TTVI). [DEVICES THAT WERE ASSOCIATED WITH THE STUDY]. THE ARTICLE CONCLUDED THAT IN THE TRIVALVE REGISTRY, THE TRI-SCORE HAS A SUBOPTIMAL PERFORMANCE IN PREDICTING CLINICAL OUTCOMES. HOWEVER, A TRISCORE GREATER THAN OR EQUAL TO 8 IS ASSOCIATED WITH AN INCREASED RISK OF CLINICAL EVENTS AND A LACK OF PROGNOSTIC BENEFIT AFTER SUCCESSFUL TTVI. THE PRIMARY AND CORRESPONDENCE AUTHOR OF THE ARTICLE IS MARIANNA ADAMO, MD, DEPARTMENT OF MEDICAL AND SURGICAL SPECIALTIES, RADIOLOGICAL SCIENCES, AND PUBLIC HEALTH, UNIVERSITY OF BRESCIA, PIAZZALE SPEDALI CIVILI 1, BRESCIA 25123, ITALY. E-MAIL: [email protected]. THE TIME FRAME OF THE STUDY WAS 2010 TO 2020. SAY NOT CONFIRMED OR REPORTED IF APPLICABLE. A TOTAL OF 634 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 416 RECEIVED A MITRACLIP AND 63 RECEIVED A TRICLIP. THE AVERAGE AGE OF THE PATIENTS ENROLLED WAS 77. THE MAJORITY GENDER WAS FEMALE. AS THIS IS FROM A LITERATURE REVIEW, PATIENT WEIGHT WAS NOT PROVIDED. COMORBIDITIES INCLUDE: PRIOR MYOCARDIAL INFARCTION, PREVIOUS LEFT-SIDED (LS) INTERVENTION, DIABETES, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), CHRONIC KIDNEY DISEASE (CKD) ON DIALYSIS, ATRIAL FIBRILLATION, CARDIAC IMPLANTABLE ELECTRONIC DEVICE (CIED), HEART FAILURE HOSPITALIZATION, HEART FAILURE, PERIPHERAL EDEMA, TRICUSPID REGURGITATION (TR GRADE SEVERITY: 2,3,4). PERI AND POST-PROCEDURAL COMPLICATIONS INCLUDED CONVERSION TO SURGERY, TRICUSPID REGURGITATION, BLOOD TRANSFUSION, ACUTE KIDNEY INJURY, DIALYSIS, PERICARDIAL EFFUSION, LOW -CARDIAC OUTPUT SYNDROME, STROKE, INFECTION, NEW ATRIAL FIBRILLATION, IN-HOSPITAL DEATH, AND HEART FAILURE HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421167 TRICLIP DELIVERY SYSTEM (TCDS) TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death