BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERFLEX P3 PTA DILATATION CATHETER

    MDR report key: 1082249 · Received July 24, 2008

    Report

    Report Number
    9610978-2008-00194
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    April 30, 2008
    Report Date
    June 17, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS STUDY PT UNDERWENT PERCUTANEOUS ANGIOPLASTY TO THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA); DURING THIS PROCEDURE, THE PT SUFFERED A FEMORAL ACCESS SITE HEMATOMA AND A FEMORAL ARTERY DISSECTION,. THE PT WAS A MALE WITH MEDICAL HISTORY INCLUDING PERIPHERAL VASCULAR DISEASE, BILATERAL FEMORAL ARTERY PREVIOUS INTERVENTIONS, LEFT POPLITEAL ARTERY PREVIOUS INTERVENTION, DIABETES MELLITUS, HYPERTENSION AND HISTORY OF SMOKING. THE LEFT PROXIMAL AND DISTAL SFA WERE TREATED WITH A POWERFLEX BALLOON, AT A MAXIMUM PRESSURE OF 15 ATM. THE VESSEL ANATOMY AT THE LESION SITE WAS STRAIGHT, LESION WAS DE NOVO AND THE VESSEL WAS CALCIFIED. THERE WAS NO THROMBUS PRESENT AT THE SITE. PERCENTAGE STENOSIS BEFORE PROCEDURE WAS 80% AND AFTER PTA 20%. A DISSECTION WAS REPORTED AFTER DILATION, WHICH WAS TREATED WITH REPEAT BALLOON DILATATION. AT DISCHARGE FROM THE ANGIO SUITE, IT WAS NOTED THE PT HAD A SMALL HEMATOMA AT THE ARTERIAL PUNCTURE SITE, THERE IS NO REPORTED INFO REGARDING TREATMENT OF THE HEMATOMA. PT WAS DISCHARGED ON ASPIRIN, STATINS AND METFORMIN. THE PRODUCT WAS NOT RETURNED FOR EVAL AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCT MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. HEMATOMA AND ARTERIAL DISSECTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH PERCUTANEOUS ANGIOPLASTY PROCEDURES. DUE TO THE NATURE OF THE PHYSICAL MANIPULATION OF THE FEMORAL ARTERY DURING THESE PROCEDURES, HEMATOMA IS AN ANTICIPATED EVENT. PRECAUTIONS ARE IMPLEMENTED TO PREVENT THE DEVELOPMENT OF A HEMATOMA. FURTHER, THE ANTICOAGULATION MEDICATION REGIMEN REQUIRED IN INTERVENTIONAL PROCEDURES PREDISPOSES PATIENTS TO BLEEDING COMPLICATIONS; COUPLING THIS WITH THE MANIPULATION OF THE ARTERY, THE CHANCES FOR HEMATOMA ARE INCREASED SIGNIFICANTLY. REVIEW OF THE INFO SUGGESTS, THERE WERE PT FACTORS THAT MAY HAVE CONTRIBUTED TO THE ARTERY DISSECTION, SPECIFICALLY THE PATIENT'S HISTORY OF PERIPHERAL VASCULAR DISEASE AND THE VESSEL'S CALCIFICATION.

    Description of Event or Problem · 1

    DURING AN ANGIOPLASTY PROCEDURE OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) THERE WAS A DISSECTION OF THE TARGET VESSEL. THE PT IS A MALE WITH MEDICAL HISTORY INCLUDING PERIPHERAL VASCULAR DISEASE, BILATERAL FEMORAL ARTERY PREVIOUS INTERVENTIONS, LEFT POPLITEAL ARTERY PREVIOUS INTERVENTION, DIABETES MELLITUS, HYPERTENSION AND HISTORY OF SMOKING. THE TARGET LESION WAS THE LEFT PROXIMAL AND DISTAL SFA. ACCESS METHOD WAS PERCUTANEOUS AND PUNCTURE SITE CONTRALATERAL. THE VESSEL ANATOMY AT THE LESION SITE WAS STRAIGHT, THE TYPE OF LESION WAS DE NOVO, AND THE VESSEL WAS CALCIFIED. THERE WAS NO THROMBUS PRESENT AT THE TARGET SITE. LESION LOCATION WAS 3CM ABOVE THE SUPERIOR EDGE OF THE PATELLA. TOTAL LESION LENGTH WAS 200MM NOT OCCLUDED. THE SFA WAS TREATED WITH A CORDIS POWERFLEX BALLOON (6X40MM), AT A MAXIMUM PRESSURE OF 15 ATM. FOLLOWING BALLOON EXPANSION, THERE WAS A DISSECTION AT THE LESION SITE. THE DISSECTION WAS TREATED REPEAT BALLOON DILATATION. THE PT WAS DISCHARGED THE NEXT DAY. AFTER THE PROCEDURE, IT WAS NOTED THAT THERE WAS A SMALL HEMATOMA AT THE PUNCTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R0707317

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R DEVICES: STORQ 0.035 INCH GUIDEWIRE| ASPIRIN| HEPARIN| ISOKET| METFORMIN