BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTRANT INTRODUCER SHEATH

    MDR report key: 20155156 · Received September 6, 2024

    Report

    Report Number
    9612164-2024-04088
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 11, 2023
    Report Date
    October 14, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DYB
    PMA / PMN Number
    K123990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED PER THE PHYSICIAN THERE IS NO CAUSAL RELATIONSHIP BETWEEN THE SENTRANT SHEATH AND THE DEATHS OR ADVERSE EVENTS. 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.

    Additional Manufacturer Narrative · 0

    CITATION: AUTHORS:STEFANO GENNAI Z, FRANCESCO ANDREOLI Z, NICOLA LEONE *, LUIGI ALBERTO MARIA BARTOLOTTI, GIANMARCO MALETI, ROBERTO SILINGARDI PROGNOSTIC BENEFITS OF EARLY VASCULAR SURGICAL INTERVENTION IN PATIENTS WITH MAJOR PERIPHERAL VASCULAR COMPLICATIONS FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION HELLENIC JOURNAL OF CARDIOLOGY VOL. 77, 2024: 1 ¿ 1 2 HTTPS://DOI.ORG/10.1016/J.HJC.2023.08.007 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. 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 'PROGNOSTIC BENEFITS OF EARLY VASCULAR SURGICAL INTERVENTION IN PATIENTS WITH MAJOR PERIPHERAL VASCULAR COMPLICATIONS FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION. THE TIME FRAME OF THIS STUDY WAS OVER 10 YEARS FROM '2009 TO 2019.' THE FOLLOWING MEDTRONIC DEVICES WERE USED: 14FR SENTRANT SHEATHS IN TAVR PROCEDURES AMONG PATIENT ADVERSE EVENTS INCLUDED: HEMATOMAS, ARTERIAL DISSECTIONS PSEUDOANEURYSM THROMBUS OF THE EXTERNAL ILIAC ARTERY LEADING TO ACUTE LIMB ISCHEMIA FISTULA PERFORATION BLEEDING OVERALL POST-OPERATIVE ISSUES INCLUDED PROLONGED PROCEDURES, INCREASED RADIATION EXPOSURE, EXTENDED STAYS IN INTERMEDIATE CARE UNIT (IMCU) AND HOSPITAL, AND SIGNIFICANT DIFFERENCES IN DURATION OF PROCEDURES AND AREA DOSAGE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2046001 SENTRANT INTRODUCER SHEATH INTRODUCER, CATHETER DYB MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention