BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 2220404 · Received August 23, 2011

    Report

    Report Number
    2134265-2011-03400
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT DEVICE EVALUATED BY MANUFACTURER - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THROMBOSIS AND IN-STENT RESTENOSIS OCCURRED. STATUS POST SURGICAL REPAIR OF THE LEFT HIP SECONDARY TO FRACTURE, THE PATIENT WAS TRANSFERRED FROM A NURSING HOME WITH CHEST PAIN AND DIFFICULTY SWALLOWING. ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. THE 70-80% LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY; FOLLOWED BY AN 80-90% LESION BEING TREATED IN THE 1ST DIAGONAL (DX) ARTERY. A 2.5X6MM FLEXTOME CUTTING BALLOON WAS INFLATED TO 10ATM FOR 6 SECONDS IN THE MID LAD. THE PHYSICIAN DEPLOYED A 3.0X12MM VERIFLEX STENT, INFLATED TO 12ATM FOR 10 SECONDS. THE STENT WAS POST DILATED WITH A 3.0X8MM QUANTUM APEX BALLOON, INFLATED TO 12ATM FOR 10 SECONDS. A 3.0X18MM PROMUS STENT WAS IMPLANTED, INFLATED TO 12ATM FOR 10 SECONDS. ZERO - 10% RESIDUAL STENOSIS REMAINED. THEN THE PHYSICIAN PREDILATED THE DX USING 2.0X9MM MAVERICK BALLOON, INFLATED TO 8ATM FOR 10 SECONDS. A 2.0X6MM FLEXTOME CUTTING BALLOON WAS INFLATED TO 12ATM FOR 10 SECONDS. A 2.50X12MM PROMUS STENT WAS IMPLANTED, INFLATED TO 10ATM FOR 10 SECONDS. THEN THE STENT WAS POST DILATED USING A 2.25X15MM QUANTUM APEX BALLOON, INFLATED TO 12ATM FOR 10 SECONDS. 0-10% RESIDUAL STENOSIS REMAINED. MEDICATIONS GIVEN INCLUDED: ANGIOMAX, INTEGRILIN DOUBLE BOLUS, AND IC NTG. PATIENT WAS PRESCRIBED PLAVIX. TWO DAYS LATER, THE PATIENT PRESENTED WITH A SUDDEN DROP IN HEMOGLOBIN AND RECURRENT ANGINAL SYMPTOMS. ECG SHOWED STEMI IN V2-V3 WITH RECIPROCAL CHANGES. PATIENT WAS TAKEN EMERGENTLY TO THE CATH LAB WHILE BEING TRANSFUSED. ACCESS WAS GAINED VIA THE LEFT FEMORAL ARTERY. THE LAD AND DX WERE FOUND TO BE TOTALLY OCCLUDED WITH THROMBUS. TWO PASSES WITH A NON-BSC ASPIRATION CATHETER WERE MADE IN THE PROXIMAL LAD. INFLATIONS WERE PERFORMED WITH A NON-BSC BALLOON AND A 3.0X12MM BALLOON. THE PHYSICIAN PREDILATED WITH A 2.50X12MM MAVERICK2 BALLOON, INFLATED TO 12ATM FOR 10 SECONDS, AND DEPLOYED A 3X15MM PROMUS STENT, INFLATED TO 10ATM FOR 10 SECONDS. THE STENT WAS POST DILATED USING A 3.25X15MM QUANTUM APEX BALLOON, INFLATED TO 18ATM FOR 10 SECONDS. 0-10% RESIDUAL STENOSIS REMAINED. TWO PASSES WITH A NON-BSC ASPIRATION CATHETER WERE MADE IN THE MID LAD. INFLATIONS WERE PERFORMED WITH A 3.0X12MM AND 3.25X15 QUANTUM APEX BALLOON, INFLATED TO 16-18ATM FOR 10 SECONDS. 0-10% RESIDUAL STENOSIS REMAINED. ONE PASS WITH A NON-BSC ASPIRATION CATHETER WAS MADE IN THE DISTAL LAD. THE PHYSICIAN DEPLOYED 3 PROMUS STENTS (2.5X28MM, 2.5X15MM, 2.25X15MM), INFLATED TO 10ATM FOR 10 SECONDS, AND DEPLOYED A 3X15MM PROMUS STENT, INFLATED TO 10ATM FOR 10 SECONDS. ZERO - 10% RESIDUAL STENOSIS REMAINED. FINALLY, TWO PASSES WITH A NON-BSC ASPIRATION CATHETER WERE MADE IN THE MID LAD. INFLATIONS WERE PERFORMED WITH A 2.5X12MM MAVERICK BALLOON, INFLATED TO 12ATM FOR 10 SECONDS. ZERO - 10% RESIDUAL STENOSIS REMAINED. THE PHYSICIAN WAS UNABLE TO KEEP THE LAD AND DX OPEN. THE DX WAS JAILED WITH THE PROXIMAL STENT. MEDICATIONS GIVEN INCLUDED: PLAVIX, ASPIRIN, AND INSULIN. PATIENT WAS PRESCRIBED EFFIENT, INSTEAD OF PLAVIX. FOUR DAYS LATER, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. PATIENT WAS INTUBATED AND STEMI CODE WAS ACTIVATED. IN-STENT RESTENOSIS (THROMBOTIC) WAS IDENTIFIED IN THE TOTALLY OCCLUDED MID LAD. ONE PASS WITH A NON-BSC ASPIRATION CATHETER WAS MADE IN THE MID LAD. INFLATIONS WERE PERFORMED WITH 3 APEX BALLOONS ([2]1.5X12MM, 1.5X8MM), 4 MAVERICK BALLOONS (2.0X12MM, 3.0X20MM, [2] 2.5X9MM), AND A 2.0X8MM QUANTUM APEX BALLOON, INFLATED TO 1-14ATM FOR 1-10 SECONDS. ZERO - 10% RESIDUAL STENOSIS REMAINED. AN INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED DUE TO SLOW FLOW. THE PATIENT WAS TRANSFERRED FOR EMERGENT CORONARY ARTERY BYPASS GRAFT (CABG). MEDICATIONS GIVEN INCLUDED: ANGIOMAX. FOLLOWING CABG, NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE UNK208

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention