BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 22160025 · Received June 6, 2025

    Report

    Report Number
    9612164-2025-02775
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    July 24, 2024
    Report Date
    June 6, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A LATENT BLEEDING COMPLICATION IN IPSILATERAL COMMON FEMORAL PUNCTURE INVOLVING DELAYED DIAGNOSIS: A CASE REPORT NOMURA ET AL. BMC CARDIOVASCULAR DISORDERS (2024) 24:342 HTTPS://DOI.ORG/10.1186/S12872-024-04006-7 BMC CARDIOVASCULAR DISORDERS B3 DATE OF PUBLICATION. 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

    THE TRANS FEMORAL IPSILATERAL APPROACH IS OFTEN ADOPTED FOR ENDOVASCULAR TREATMENT (EVT) FOR BETTER STEERABILITY OF GUIDEWIRES OR BETTER DEVICE DELIVERABILITY. HOWEVER, CONTRARY TO THE TRANS FEMORAL CONTRALATERAL APPROACH, IPSILATERAL ANTEGRADE PUNCTURE SOMETIMES CAUSES PECULIAR BLEEDING COMPLICATIONS. CASE PRESENTATION A 76-YEAR-OLD FEMALE UNDERWENT EVT FOR CHRONIC OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) VIA THE IPSILATERAL ANTEGRADE APPROACH. AFTER GUIDEWIRE PASSAGE, WE INFLATED THE DRUG-COATED BALLOONS, BUT ANGIOGRAPHY SHOWED BLOOD FLOW STASIS AT THE MID SEGMENT OF THE SFA. WE ALSO ENSURED PROLONGED BALLOON INFLATION, WHICH RESULTED IN FAVORABLE BLOOD FLOW. WHILE TRYING TO ENSURE HEMOSTASIS, THE BLOOD PRESSURE REMAINED DECREASED, BUT NEITHER BLEEDING NOR SUPERFICIAL HEMATOMA WERE OBSERVED AT THE PUNCTURE SITE. AFTER HEMOSTASIS WAS ACHIEVED, WE REMOVED THE SURGICAL DRAPE AND NOTICED A SWELLING IN THE MID-PORTION OF THE THIGH, DISTANT FROM THE PUNCTURE POINT. WE THEN APPROACHED THE LEFT COMMON FEMORAL ARTERY (CFA) CONTRALA TERALLY. ANGIOGRAPHY SHOWED CONTINUOUS BLEEDING FROM A LITTLE BIT DISTALLY TO THE SHEATH INSERTION POINT THAT WAS SPREADING THROUGH AN INTRAMUSCULAR SPACE. WE STOPPED THE BLEEDING WITH BALLOON TAMPONADE INSIDE THE CFA. ANGIOGRAPHY AFTER HEMOSTASIS DEMONSTRATED BLOOD FLOW STASIS AT THE MID-SEGMENT OF THE SFA, SIMILARLY AS THAT SEEN BEFORE. WE CONFIRMED COMPRESSION OF THE SFA BY A LARGE HEMATOMA USING BOTH INTRA- AND EXTRA- VASCULAR ULTRASOUND. THEREFORE, WE DEPLOYED A SELF-EXPANDABLE STENT AT THE COMPRESSED SFA POSITION. FINALLY, WE ACHIEVED FAVORABLE BLOOD FLOW ON ANGIOGRAPHY. CONCLUSION WE ENCOUNTERED A CASE THAT LATENT BLEEDING UNRECOGNIZED IN THE SURGICAL FIELD PERSISTED WHILE PROLONGED INFLATION OF DCB WAS CONDUCTED AT JUST PROXIMAL SFA. WE COULD HAVE AVOIDED BAILOUT STENTING BY NOTICING THE BLEEDING INCIDENT IN A TIMELY MANNER. PREDICTION AND PREVENTION ARE ESSENTIAL FOR ALL KINDS OF PROCEDURAL COMPLICATIONS IN EVT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603344 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS ONU MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention