BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION¿

    MDR report key: 2232930 · Received September 2, 2011

    Report

    Report Number
    2134265-2011-03866
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED PRODUCT CONSISTED OF A TAXUS ELEMENT/ION STENT DELIVERY SYSTEM (SDS). THERE WAS CONTRAST IN THE INFLATION LUMEN AND BALLOON AND A DRIED BLOOD LIKE SUBSTANCE ON THE SURFACE OF THE BALLOON. THE BALLOON WAS LOOSELY FOLDED. THE DISTAL EDGE OF THE STENT WAS 14MM FROM THE DISTAL MARKERBAND. NO STRUT IMPRESSIONS WERE VISIBLE ON THE SURFACE OF THE BALLOON BETWEEN THE DISTAL END OF THE STENT AND THE DISTAL MARKERBAND. THERE WERE BENT AND FLARED STRUTS THROUGHOUT THE STENT. THERE WAS NO DAMAGE TO THE SDS. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY (RCA). USING A 6FR SHEATH AND NON-BSC GUIDE CATHETER, A 4.0X32MM ION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. HOWEVER, RESISTANCE WAS ENCOUNTERED AS THE SDS WAS ADVANCED THROUGH THE GUIDE CATHETER. ONCE THE DISTAL END OF THE SDS EXITED THE DISTAL PORTION OF THE GUIDE CATHETER INSIDE THE PATIENT, IT WAS NOTED THAT THERE WAS NO STENT ON THE BALLOON. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT AND THE STENT WAS FOUND TO BE CRUMPLED AND STUCK TO THE PROXIMAL PORTION OF THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER GUIDE CATHETER AND A SHORTER STENT. DURING THE SAME PROCEDURE, A 3.0X28MM PROMUS STENT DELIVERY SYSTEM FAILED TO CROSS A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) AFTER PREDILATING WITH A 3.0MM APEX. THE LAD WAS SUCCESSFULLY TREATED WITH TWO 3.0X18MM PROMUS STENTS WITH A GOOD OUTCOME. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY (RCA). USING A 6FR SHEATH AND NON-BSC GUIDE CATHETER, A 4.0X32MM ION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. HOWEVER, RESISTANCE WAS ENCOUNTERED AS THE SDS WAS ADVANCED THROUGH THE GUIDE CATHETER. ONCE THE DISTAL END OF THE SDS EXITED THE DISTAL PORTION OF THE GUIDE CATHETER INSIDE THE PATIENT, IT WAS NOTED THAT THERE WAS NO STENT ON THE BALLOON. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT AND THE STENT WAS FOUND TO BE CRUMPLED AND STUCK TO THE PROXIMAL PORTION OF THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER GUIDE CATHETER AND A SHORTER STENT. DURING THE SAME PROCEDURE, A 3.0X28MM PROMUS STENT DELIVERY SYSTEM FAILED TO CROSS A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) AFTER PREDILATING WITH A 3.0MM APEX. THE LAD WAS SUCCESSFULLY TREATED WITH TWO 3.0X18MM PROMUS STENTS WITH A GOOD OUTCOME. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902432400

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR GUIDELINER GUIDE CATHETER