BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2232893 · Received September 2, 2011

    Report

    Report Number
    2134265-2011-03758
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE RETURNED PRODUCT CONSISTED OF A TAXUS ELEMENT/ION STENT DELIVERY SYSTEM (SDS), A GUIDE WIRE, RUNWAY GUIDE CATHETER, AND A Y-ADAPTER. THE BALLOON WAS TIGHTLY FOLDED WITH STENT IMPRESSIONS VISIBLE BETWEEN THE MARKERBANDS. THE LOCATION OF THE STENT IMPRESSIONS ON THE BALLOON INDICATE THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE SDS IN MANUFACTURING. THE STENT WAS RECEIVED ON THE GUIDE WIRE. THE ENTIRE LENGTH OF THE STENT WAS STRETCHED. THERE WAS NO DAMAGE TO THE SDS. THE DEVICE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION STENT DISLODGEMENT OCCURRED. AS THE PHYSICIAN ADVANCED THE 3.0X38MM ION STENT INTO A NON-BSC GUIDE CATHETER THE STENT DISLODGED FROM THE BALLOON. THE DISLODGED STENT REMAINED ON THE STENT DELIVERY SYSTEM (SDS). THE NON-BSC GUIDE CATHETER AND SDS WERE REMOVED AS A UNIT AND THE DISLODGED STENT WAS RECOVERED. THE PHYSICIAN DID NOT ENCOUNTER ANY RESISTANCE THAT HE FEELS WOULD HAVE CONTRIBUTED TO THE STENT DISLODGEMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.0X38MM ION STENT. 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 PERCUTANEOUS CORONARY INTERVENTION STENT DISLODGEMENT OCCURRED. AS THE PHYSICIAN ADVANCED THE 3.0X38MM ION STENT INTO A NON-BSC GUIDE CATHETER THE STENT DISLODGED FROM THE BALLOON. THE DISLODGED STENT REMAINED ON THE STENT DELIVERY SYSTEM (SDS). THE NON-BSC GUIDE CATHETER AND SDS WERE REMOVED AS A UNIT AND THE DISLODGED STENT WAS RECOVERED. THE PHYSICIAN DID NOT ENCOUNTER ANY RESISTANCE THAT HE FEELS WOULD HAVE CONTRIBUTED TO THE STENT DISLODGEMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.0X38MM ION STENT. 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 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902338300 14108963

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GUIDE CATHETER: GUIDELINER