BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX¿

    MDR report key: 2863046 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07259
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION CONFIRMED A HYPOTUBE BREAK 68.5CM FROM THE STRAIN RELIEF. A KINK WAS PRESENT 65.5CM FROM THE STRAIN RELIEF ALSO. THIS IS CONSISTENT WITH FORCE BEING APPLIED TO THE DEVICE DURING HANDLING/USE. A MICROSCOPIC EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES. IT WAS NOT POSSIBLE TO INFLATE THE BALLOON AS THE SHAFT WAS RETURNED IN TWO SECTIONS. A VISUAL EXAMINATION OF THE BALLOON AND TIP IDENTIFIED NO ISSUES. 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 STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE PATIENT PRESENTED TO THE CATH LAB EMERGENTLY WITH AN ACUTE MYOCARDIAL INFARCTION. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 2.5X15MM APEX BALLOON AT 5ATMS FOR 5 SECONDS. A 3.00X24MM VERIFLEX STENT DELIVERY SYSTEM (SDS) ALONG WITH A FORTE GUIDE WIRE WERE THEN ADVANCED TO THE LESION. WHEN THE PHYSICIAN PULLED NEGATIVE, IT WAS NOTED THAT BLOOD WAS PULLED BACK INTO THE DEVICE. THE PHYSICIAN ATTEMPTED TO REMOVE THE VERIFLEX SDS FROM THE PATIENT; HOWEVER, THE DISTAL PORTION OF THE DEVICE WITH THE STENT ON IT REMAINED IN THE BODY. THE PHYSICIAN THEN REMOVED THE WIRE AND THE DISTAL PORTION OF THE SDS CAME WITH IT. THE LESION WAS RE-WIRED WITH A LONGER FORTE GUIDE WIRE AND THE LESION WAS DILATED WITH A 2.75X15MM APEX BALLOON AT 10ATMS FOR 3 SECONDS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 3.00X24MM VERIFLEX STENT WHICH WAS DEPLOYED AT 17ATMS FOR 16 SECONDS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE PATIENT PRESENTED TO THE CATH LAB EMERGENTLY WITH AN ACUTE MYOCARDIAL INFARCTION. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 2.5 X 15 MM APEX BALLOON AT 5 ATMS FOR 5 SECONDS. A 3.00 X 24 MM VERIFLEX STENT DELIVERY SYSTEM (SDS) ALONG WITH A FORTE GUIDE WIRE WERE THEN ADVANCED TO THE LESION. WHEN THE PHYSICIAN PULLED NEGATIVE, IT WAS NOTED THAT BLOOD WAS PULLED BACK INTO THE DEVICE. THE PHYSICIAN ATTEMPTED TO REMOVE THE VERIFLEX SDS FROM THE PATIENT; HOWEVER, THE DISTAL PORTION OF THE DEVICE WITH THE STENT ON IT REMAINED IN THE BODY. THE PHYSICIAN THEN REMOVED THE WIRE AND THE DISTAL PORTION OF THE SDS CAME WITH IT. THE LESION WAS RE-WIRED WITH A LONGER FORTE GUIDE WIRE AND THE LESION WAS DILATED WITH A 2.75 X 15 MM APEX BALLOON AT 10 ATMS FOR 3 SECONDS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 3.00 X 24 MM VERIFLEX STENT WHICH WAS DEPLOYED AT 17 ATMS FOR 16 SECONDS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893424300 13380148

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention 2.5 X 15 APEX BALLOON CATHETER| FORTE GUIDE WIRE