BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTRANT INTRODUCER SHEATH

    MDR report key: 23521903 · Received November 11, 2025

    Report

    Report Number
    9612164-2025-05550
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    October 31, 2025
    Report Date
    December 10, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DYB
    UDI-DI
    00763000716257
    PMA / PMN Number
    K123990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: S ENSH1228W, SERIAL/LOT #: (B)(6), UBD: 22-JUL-2026, UDI#: (B)(4). 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

    PRODUCT ANALYSIS CONCLUSION: THE REPORTED VESSEL PERFORATION AND BLOOD EXTRAVASATION WERE CONFIRMED IN THE PROVIDED FILMS; HOWEVER, THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED. LACK OF PRE-IMPLANT CT IMAGING LIMITED A THOROUGH ASSESSMENT OF THE PRE-IMPLANT ANATOMY. THE ANGIOGRAMS INCLUDED SEVERAL BRIEF VIDEOS, SOME DEPICTING A SHEATH POSITIONED WITHIN THE VESSEL, BUT THESE DID NOT CAPTURE DYNAMIC SEQUENCES OF SHEATH ADVANCEMENT; THE DYNAMIC PORTIONS WERE RELATED TO CONTRAST INJECTION, SO THE EXACT MOMENT WHEN THE VESSEL DAMAGE OCCURRED COULD NOT BE IDENTIFIED. IT IS POSSIBLE THAT VESSEL IRREGULARITY, INDICATING POSSIBLE CALCIFICATION, MAY HAVE CONTRIBUTED TO INCREASED SUSCEPTIBILITY TO VESSEL DAMAGE AND SUBSEQUENT BLEEDING DURING DEVICE MANIPULATION. 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

    TWO SENTRANT SHEATHS WERE USED AS A CONDUIT DURING A TAVI PROCEDURE . IT WAS NOTED THAT THE PATIENT PRESENTED WITH BORDERLINE DIAMETERS AND SEVERE CALCIFICATION IN REGIONS OF THE RIGHT AND LEFT COMMON ILIAC ARTERIES, AND THE RIGHT AND LEFT COMMON FEMORAL ARTERIES. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE TREATMENT OF THE COMMON ILIAC AND RIGHT COMMON FEMORAL ARTERIES WAS PERFORMED. SUBSEQUENTLY, THE 26 FX VALVE (LOT K128644) WAS MOUNTED ON THE DELIVERY SYSTEM (LOT 12526098), WITH SATISFACTORY FLUOROSCOPIC VERIFICATION. PRE-DILATION WAS PERFORMED WITH A 18 X 40 NON-MEDTRONIC BALLOON. DURING THE ATTEMPT TO INSERT THE DELIVERY SYSTEM THROUGH THE RIGHT COMMON FEMORAL ARTERY, IT WAS OBSERVED THAT, DUE TO SEVERE CALCIFICATION, THERE WAS NO PROGRESSION OF THE SYSTEM. SEQUENTIAL DILATION OF THE ARTERY WAS THEN PERFORMED WITH SENTRANT 12 FR, A 14 FR NON-MEDTRONIC DEVICE , AND SENTRANT 16 FR INTRODUCERS. HOWEVER, EVEN AFTER THE DILATIONS, THE DELIVERY SYSTEM DID NOT PROGRESS. SHORTLY AFTER, THE PATIENT PRESENTED WITH BLEEDING IN THE REGION OF THE RIGHT COMMON FEMORAL ARTERY AND HYPOTENSION, DUE TO VESSEL PERFORATION. ANGIOPLASTY WITH A 7X50 COVERED STENT WAS PERFORMED, FOLLOWED BY POST-DILATION OF THE STENT WITH A PERIPHERAL BALLOON. THE VASCULAR SURGERY TEAM WAS CALLED IN AND CONFIRMED THAT THE BLEEDING HAD RESOLVED. DUE TO THE PATIENT'S HEMODYNAMIC INSTABILITY, THE MEDICAL TEAM OPTED NOT TO PROCEED WITH THE VALVE IMPLANT AT THIS TIME, SCHEDULING A NEW PROCEDURE WITH AN ALTERNATIVE APPROACH AS SOON AS CLINICAL STABILIZATION IS ACHIEVED. THE PATIENT REMAINS IN HOSPITAL AWAITING HEALTH INSURANCE AUTHORIZATION OF A NEW TAVI PROCEDURE VIA AN ALTERNATIVE ACCESS. PER THE PHYSICIAN THE CAUSE OF THE VESSEL PERFORATION WAS ANATOMY RELATED DUE TO SEVERE CALCIFICATION IN THE RIGHT COMMON FEMORAL ARTERY. IT WAS ALSO STATED THAT THE SENTRANT SHEATHS CONTRIBUTED TO THE EVET DUE TO MULTIPLE ATTEMPTS TO INSERT THE DEVICE INTO THE VESSEL. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2542105 SENTRANT INTRODUCER SHEATH INTRODUCER, CATHETER DYB MEDTRONIC IRELAND SENSH1628W P2F25B0034 00763000716257

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention| O "SEE H11....".