BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX¿

    MDR report key: 2770970 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-06016
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE MIDSHAFT. THE BREAK WAS LOCATED AT 2.5CM DISTAL TO THE PROXIMAL EDGE OF THE MIDSHAFT. HOWEVER, IT WAS ALSO NOTED THAT THE MIDSHAFT WAS SEVERELY STRETCHED. AN EXAMINATION OF THE PROXIMAL WELD SITE CONFIRMED THAT THE WELD WAS NOT NECKED DOWN. THE BALLOON WAS FULLY DEFLATED BUT WAS NOT REFOLDED CORRECTLY. AS A RESULT THE BALLOON FOLDS AT THE DISTAL END OF THE BALLOON WERE OPENED OUTWARDLY. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON DEFLATION ISSUE AND A SHAFT FRACTURE OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN THE NON CALCIFIED AND NON TORTUOUS MID SAPHENOUS VEIN GRAFT (SVG) TO THE POSTERIOR DESCENDING ARTERY (PDA). THE 5.0 X 32MM VERIFLEX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER A 190 CM FILTERWIRE GUIDE WIRE AND THROUGH A 6 FRENCH NON BSC GUIDE CATHETER. THE SDS WAS DEPLOYED AT 10ATMS AND THE INFLATION DEVICE WAS PULLED NEGATIVE; HOWEVER, THE BALLOON DID NOT APPEAR TO COMPLETELY DEFLATE. AS THE PHYSICIAN WAS PULLING THE PARTIALLY DEFLATED DEVICE INTO THE GUIDE CATHETER IT MET MINIMAL RESISTANCE AND THE DISTAL PORTION SEPARATED. THE COMPLETE SDS, GUIDE WIRE, AND GUIDE CATHETER WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON DEFLATION ISSUE AND A SHAFT FRACTURE OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN THE NON CALCIFIED AND NON TORTUOUS MID SAPHENOUS VEIN GRAFT (SVG) TO THE POSTERIOR DESCENDING ARTERY (PDA). THE 5.0 X 32MM VERIFLEX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER A 190 CM FILTERWIRE GUIDE WIRE AND THROUGH A 6 FRENCH NON BSC GUIDE CATHETER. THE SDS WAS DEPLOYED AT 10ATMS AND THE INFLATION DEVICE WAS PULLED NEGATIVE; HOWEVER, THE BALLOON DID NOT APPEAR TO COMPLETELY DEFLATE. AS THE PHYSICIAN WAS PULLING THE PARTIALLY DEFLATED DEVICE INTO THE GUIDE CATHETER IT MET MINIMAL RESISTANCE AND THE DISTAL PORTION SEPERATED. THE COMPLETE SDS, GUIDE WIRE, AND GUIDE CATHETER WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893432500 14317990

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other MACH 1 6 FRENCH: GUIDE CATHETER| FILTERWIRE 190 CM: GUIDE WIRE