BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1812804 · Received July 10, 2010

    Report

    Report Number
    2024168-2010-01433
    Event Type
    Injury
    Date Received
    July 10, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 23, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VOYAGER NC CORONARY DILATATION CATHETER (LOT 1011755-20, LOT 0012761) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EVAL SUMMARY: FACTORS THAT CAN CONTRIBUTE TO DIFFICULTY DEPLOYING A STENT DUE TO STENT RECOIL CAN INCLUDE, BUT ARE NOT LIMITED TO, PT ANATOMICAL MORPHOLOGY, LESION CHARACTERISTICS, PT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE, PRODUCT SIZE SELECTION, AND/OR LESION SIZE. IN THIS CASE, THE RESTENOSIS REQUIRED TREATMENT WITH FURTHER BALLOON DILATATIONS, RESULTING IN FURTHER HOSPITALIZATION. IT SHOULD BE NOTED THAT THE XIENCE V INSTRUCTIONS FOR USE LISTS RESTENOSIS AS A KNOWN ADVERSE EFFECT OF CORONARY STENTING. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY DEPLOYING THE STENT COULD NOT BE DETERMINED. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE ADVERSE EVENT: MEDICAL INTERVENTION TO TREAT IN STENT RESTENOSIS (ISR)/XIENCE V. TIME OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT IN-STENT RESTENOSIS (ISR) OF A XIENCE V STENT THAT HAD BEEN PREVIOUSLY DEPLOYED (DATE OF STENT DEPLOYMENT IS UNK). THE ISR WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA), WHICH WAS HEAVILY CALCIFIED. IVUS WAS PERFORMED AND THE STENT WAS REPORTEDLY UNDER DEPLOYED (RECOILED). A 2.0 VOYAGER WAS USED FOR PRE-DILATION WITHOUT AN ISSUE. A 3.5 X 20 NC VOYAGER WAS USED WITH AN AL1 6FR GUIDING CATHETER AND A NON-ABBOTT GUIDE WIRE (SHORT LENGTH). THE NC VOYAGER WAS ADVANCED TO THE ISR AND UPON INFLATION THE BALLOON RUPTURED AT 10 ATMOSPHERE. DURING REMOVAL OF THE NC VOYAGER THERE WAS RESISTANCE AND THE SHAFT OF THE DEVICE SEPARATED. A SNARE DEVICE WAS USED TO PULL THE SEPARATED PORTION OF THE BALLOON CATHETER INTO THE GUIDING CATHETER AND THE TWO DEVICES WERE SUCCESSFULLY REMOVED AS A SINGLE UNIT. THE VESSEL WAS REWIRED AND TWO ADDITIONAL BALLOON CATHETERS WERE USED TO TREAT THE ISR WITH GOOD RESULTS. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE. USER FACILITY MEDWATCH RECEIVED STATES, "BALLOON RUPTURE RESULTING IN BALLOON WIRE BREAKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R VOYAGER NC CORONARY DILATATION CATHETER,| (LOT 1011755-20, LOT 0012761)