BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2171734 · Received July 22, 2011

    Report

    Report Number
    2134265-2011-02789
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE EVALUATED BY MFR, EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES. DEVICE EVALUATED BY MANUFACTURER: THE (B)(4) STENT DELIVERY SYSTEM (SDS) WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THE STENT WAS NOT PRESENT ON THE SDS. THERE WERE STENT STRUT IMPRESSIONS ON THE SURFACE OF THE TIGHTLY FOLDED BALLOON. THE STENT IMPRESSIONS WERE CENTERED BETWEEN THE MARKERBANDS. THERE WAS NO DAMAGE TO THE SDS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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, THE STENT DISLODGED. USING A RADIAL ACCESS, THE 2.25X20MM TARGET LESION WAS LOCATED IN THE RAMUS ARTERY WHICH WAS NEITHER CALCIFIED OR TORTUOUS. PREDILATION WAS PERFORMED WITH A 2.0X20MM NON BSC BALLOON INFLATED TO 12 ATM'S FOR 20 SECONDS. A 2.25X24MM ION STENT WAS ADVANCED TO TREAT THE TARGET LESION, REQUIRING EXCESSIVE FORCE AT THE LESION, BUT WAS NOT ABLE TO CROSS THE LESION. THE DEVICE ENTERED THE PATIENT'S BODY TWICE AND IT WAS NOTED THAT THE GUIDE SUPPORT WAS NOT IDEAL. WHEN PULLING THE STENT BACK INTO THE GUIDE CATHETER IN THE LEFT MAIN ARTERY, THE STENT WAS STRIPPED FROM THE BALLOON AND DISLODGED. THE STENT WAS SNARED FROM THE LEFT MAIN ARTERY, BUT SLIPPED AT THE ELBOW AND THEN EMBOLIZED INTO THE ULNAR ARTERY. ONCE IN THE ULNAR ARTERY, IT TOOK TIME TO SNARE THE STENT AND BRING IT AROUND FOR REMOVAL IN THE RADIAL ARTERY. THE PROCEDURE WAS ABORTED WITH AN ATTEMPT THE NEXT DAY TO PLACE A 2.0X15MM NON BSC STENT, BUT IT WAS NOT ABLE TO CROSS THE LESION. THE PATIENT WAS DISCHARGED 2 DAYS POST THE ORIGINAL PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DISLODGED. USING A RADIAL ACCESS, THE 2.25X20MM TARGET LESION WAS LOCATED IN THE RAMUS ARTERY WHICH WAS NEITHER CALCIFIED OR TORTUOUS. PREDILATION WAS PERFORMED WITH A 2.0X20MM NON BSC BALLOON INFLATED TO 12 ATM'S FOR 20 SECONDS. A 2.25X24MM ION STENT WAS ADVANCED TO TREAT THE TARGET LESION, REQUIRING EXCESSIVE FORCE AT THE LESION BUT WAS NOT ABLE TO CROSS THE LESION. THE DEVICE ENTERED THE PATIENT'S BODY TWICE AND IT WAS NOTED THAT THE GUIDE SUPPORT WAS NOT IDEAL. WHEN PULLING THE STENT BACK INTO THE GUIDE CATHETER IN THE LEFT MAIN ARTERY, THE STENT WAS STRIPPED FROM THE BALLOON AND DISLODGED. THE STENT WAS SNARED FROM THE LEFT MAIN ARTERY BUT SLIPPED AT THE ELBOW AND THEN EMBOLIZED INTO THE ULNAR ARTERY. ONCE IN THE ULNAR ARTERY, IT TOOK TIME TO SNARE THE STENT AND BRING IT AROUND FOR REMOVAL IN THE RADIAL ARTERY. THE PROCEDURE WAS ABORTED WITH AN ATTEMPT THE NEXT DAY TO PLACE A 2.0X15MM NON BSC STENT, BUT IT WAS NOT ABLE TO CROSS THE LESION. THE PATIENT WAS DISCHARGED 2 DAYS POST THE ORIGINAL PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902424220 14031154

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention 6FR EBU MEDTRONIC GUIDE CATHETER| TERUMO RUNTHROUGH GUIDE WIRE