BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTA PRO PTA DILATATION CATHETER

    MDR report key: 2183189 · Received July 28, 2011

    Report

    Report Number
    9616099-2011-00560
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    November 18, 2002
    Report Date
    December 13, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED DURING THE PROCEDURE: SCI 7F, CATHETER AND A 5F, TERUMO GUIDEWIRE .035 INCHES. INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED STENTS THROMBOSIS AFTER HAVING A DRUG ELUTING SMART STENT IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR DIABETES, TOBACCO ABUSE, HYPERTENSION, PERIPHERAL VASCULAR DISEASE, HYPERLIPIDEMIA AND FAMILY HISTORY F ATHEROSCLEROTIC DISEASE. THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY IN THE DISTAL SECTION. THE LESION WAS DESCRIBED AS DE NOVO, STRAIGHT, 40MM IN LENGTH, 4.0MM IN DIAMETER, CALCIFIED AND 100 % STENOSED. THE LESION WAS PRE-DILATED WITH A 4.0MM X 40MM OPTA PRO BALLOON AND A DISSECTION OCCURRED. THE LESION WAS THEN STENTED WITH A 6.0MM X 80MM SMART STENT AT 6 ATMS. THE REPORTED RESIDUAL STENOSIS WAS 0% WITH NO DISSECTION AT THE END OF THE PROCEDURE. APPROXIMATELY THREE YEARS LATER ANGIOGRAPHY WAS PERFORMED FOR UNKNOWN REASONS AND RESTENOSIS WAS OBSERVED AND TREATED WITH BALLOON ANGIOPLASTY. THE EVENT WAS ALSO ADJUDICATED TO BE A LATE STENT THROMBOSIS WITH TARGET LESION RESTENOSIS. THE PTA WAS SUCCESSFUL AND THE SUBJECT WAS DISCHARGED WITH ASS (LONG TERM) AND CLOPIDOGREL (4 WEEKS). THE STERILE LOT NUMBERS FOR THE DEVICES IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. DISSECTION, RESTENOSIS AND LATE STENT THROMBOSIS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH INTERVENTIONAL PROCEDURES ON THE PERIPHERAL VASCULATURE. REVIEW OF THE INFORMATION AVAILABLE SUGGESTS THOSE LESION CHARACTERISTICS (CALCIFIED AND HEAVILY STENOSED) AND/OR THE PATIENT'S EXTENSIVE MEDICAL HISTORY AND MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NOTHING IN THE INFORMATION PROVIDED TO INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY WITH A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS DE NOVO AND 40MM IN LENGTH AND THE VESSEL WAS 4MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH AN OPTA PRO BALLOON CATHETER. A DISSECTION WAS NOTED. A SIROLIMUS COATED SMART STENT WAS IMPLANTED, AT 6ATM, AND POST-DILATED. THERE WAS 0% STENOSIS POST PROCEDURE AND NO DISSECTION WAS PRESENT. APPROXIMATELY THREE YEARS AND A MONTH POST INDEX PROCEDURE, THE PATIENT THERE WAS RESTENOSIS AND A LATE STENT THROMBOSIS REQUIRING TARGET LESION REVASCULARIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTA PRO PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention