BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIDA BRECKER CURVE GUIDEWIRE

    MDR report key: 21810699 · Received April 9, 2025

    Report

    Report Number
    2025587-2025-02533
    Event Type
    Injury
    Date Received
    April 9, 2025
    Date of Event
    August 19, 2024
    Report Date
    April 9, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DQX
    PMA / PMN Number
    K132623
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: SIMRAT KAUR ET AL. OUTCOMES OF CARDIAC TAMPONADE POST-TRANSCATHETER AORTIC VALVE REPLACEMENT: RESULTS FROM A TERTIARY CARDIAC CENTER. STRUCTURAL HEART VOL 9, 100356 2025. 10.1016/J.SHJ.2024.100356. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING OUTCOMES OF CARDIAC TAMPONADE POST-TRANSCATHETER AORTIC VALVE REPLACEMENT. THE STUDY POPULATION INCLUDED 2,050 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 81.7 YEARS OLD. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; THREE PATIENTS WERE IMPLANTED WITH A MEDTRONIC COREVALVE, EVOLUT R, OR EVOLUT PRO BIOPROSTHETIC VALVE AND IN ONE PATIENT A CONFIDA GUIDEWIRE WAS UTILIZED. FOUR DEATHS OCCURRED WITHIN THE STUDY POPULATION: ONE IN-HOSPITAL, ONE WITHIN 30 DAYS, AND TWO WITHIN ONE YEAR OF IMPLANT. FOR ALL DEATHS BUT ONE, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. FOR THE ONE IN-HOSPITAL DEATH: THE PATIENT WHO UNDERWENT IMPLANT OF A MEDTRONIC EVOLUT VALVE HAD SEVERE PARAVALVULAR REGURGITATION WHICH REQUIRED IMPLANT OF A SECOND EVOLUT VALVE. SUBSEQUENTLY THE PATIENT BECAME PROFOUNDLY HYPOTENSIVE WITH EVIDENCE OF CARDIAC TAMPONADE. DESPITE EMERGENT PERICARDIOCENTESIS THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE. THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION AND UNFORTUNATELY PASSED AWAY. NO FURTHER DETAILS WERE PROVIDED ON THIS DEATH. AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: CARDIAC TAMPONADE IN SOME CASES REQUIRING PERICARDIOCENTESIS OR OPEN SURGERY, SHOCK, STROKE, ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, AND ACUTE KIDNEY INJURY. ADDITIONALLY, THE PREFORMED MEDTRONIC CONFIDA GUIDEWIRE WAS USED IN ONE PATIENT WHO DEVELOPED TAMPONADE DUE TO LEFT VENTRICLE LACERATION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816338 CONFIDA BRECKER CURVE GUIDEWIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC HEART VALVES DIVISION GWBC30

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Life Threatening| H| R