BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTRANT INTRODUCER SHEATH

    MDR report key: 25200512 · Received May 18, 2026

    Report

    Report Number
    2953200-2026-00018
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    April 18, 2026
    Report Date
    May 27, 2026
    Manufacturer
    MEDTRONIC VASCULAR
    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

    MDPI AND ACS STYLELERCHNER, T.; ZAPUSTAS, N.; SEYFARTH, M.; TIROCH, K.; HOLZHEY, D.; VORPAHL, M.M. VASCULAR COMPLICATIONS IN TRANSCATHETER AORTIC VALVE REPLACEMENT USING 14 VS. 18 FRENCH PLUG-BASED PERCUTANEOUS CLOSURE DEVICES: A PROPENSITY SCORE-MATCHED OBSERVATIONAL STUDY. J. CLIN. MED. 2026, 15, 3095. HTTPS://DOI.ORG/10.3390/JCM15083095 A2: MEAN AGE A3A: MEAN GENDER 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 ¿VASCULAR COMPLICATIONS IN TRANSCATHETER AORTIC VALVE REPLACEMENT USING 14 VS. 18 FRENCH PLUG-BASED PERCUTANEOUS CLOSURE DEVICES: A PROPENSITY SCORE-MATCHED OBSERVATIONAL STUDY¿ THE TIME FRAME OF THIS STUDY WAS OVER 1 YEAR. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: MEDTRONIC SENTRANT SHEATH. DEATHS OCCURRED IN THE STUDY POPULATION. THERE WAS NO INFORMATION TO SUGGEST ANY MEDTRONICDEVICE FAILURE CAUSED OR CONTRIBUTED TO A DEATH. AMONG PATIENT ADVERSE EVENTS INCLUDED: MAJOR VASCULAR COMPLICATIONS, MINOR VASCULAR COMPLICATIONS, BLEEDING EVENTS, VESSEL STENOSIS, VESSEL OCCLUSION, VESSEL DISSECTION, PERSISTENT BLEEDING, RETROPERITONEAL HEMATOMA REQUIRING TREATMENT WITH STENTING. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76698 SENTRANT INTRODUCER SHEATH INTRODUCER, CATHETER DYB MEDTRONIC VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention