BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2873012 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07815
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    August 21, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: DESCRIBE EVENT OR PROBLEM, UPN-SEARCH, DEVICE LOT#, DEVICE EXPIRATION DATE, DEVICE MANUFACTURED DATE. UPN CORRECTED FROM H7493911324250 TO H7493911324220. LOT CORRECTED FROM 15261738 TO 0015264714. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE IS COMBINATION PRODUCT DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT TWO SECTIONS OF THE CATHETER WERE RETURNED FOR ANALYSIS. THE PROXIMAL CATHETER SECTION MEASURES 75 CM AND INCLUDES THE MANIFOLD AND PROXIMAL SECTION OF THE HYPOTUBE. THE HYPOTUBE IS SEVERELY KINKED THROUGHOUT. THE MANIFOLD INDICATES THIS SECTION BELONGS TO A PROMUS ELEMENT SIZE 24 X 2.25 MM DEVICE (CATHETER BATCH NUMBER 15229538-105) AND NOT TO A 24 X 2.50 MM DEVICE AS PER COMPLAINT REPORT. THE DISTAL CATHETER SECTION MEASURES 27 CM AND INCLUDES THE BALLOON AND TIP AND DISTAL OUTER. THE BREAK SITE IS JUST DISTAL TO THE PORT BOND AND THE INNER IS STRETCHED AT THE BREAK SITE. BOTH INNER AND OUTER TUBING ARE KINKED THROUGHOUT THEIR FULL LENGTH. NO ISSUES WERE NOTED WITH THE CRIMPED STENT, TIP AND BALLOON OF THE DEVICE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THE MIDDLE SECTION OF THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON THE (B)(4) 2012. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE DEVICE WAS UNABLE TO CROSS THE LESION. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00 X 38 MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LAD; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED SHAFT BREAK.

    Description of Event or Problem · 1

    THE DEVICE WAS ORIGINALLY REPORTED AS A 3.00X38MM PROMUS ELEMENT STENT. THE ACTUAL DEVICE IS A 2.25X24MM PROMUS ELEMENT STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324220 0015264714

    Patients

    Seq Age Sex Outcome Treatment
    1