BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

    MDR report key: 774613 · Received October 25, 2006

    Report

    Report Number
    2024168-2006-00610
    Event Type
    Injury
    Date Received
    October 25, 2006
    Date of Event
    September 26, 2006
    Report Date
    September 27, 2006
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE DISLODGED STENT. EVALUATION SUMMARY. QUALITY ASSURANCE ANALYSIS REVEALED THAT THE CATHETER WAS NOT RETURNED. ONLY THE STENT WAS RETURNED WITH BLOOD AND TISSUE VISIBLE INSIDE AND AROUND THE STENT. THE STENT WAS RETURNED WITH A PIECE OF A SNARE DEVICE STUCK INSIDE. THE PROXIMAL END AND MIDDLE PORTION OF THE STENT WAS SEVERELY MANGLED WITH TISSUE STUCK BETWEEN THE MANGLED STRUTS. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND ANALYSIS OF THE RETURNED DEVICE. QUALITY ASSURANCE ANALYSIS CONFIRMED THAT STENT DISLODGED, AS ONLY THE STENT WAS RETURNED FOR ANALYSIS. IT APPEARS THAT THE DAMAGE TO THE STENT WAS A RESULT OF THE SNARE ATTEMPT. POTENTIAL CAUSES FOR STENT DISLODGEMENT, AS OBSERVED IN PAST INCIDENTS, MAY INCLUDE IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, IMPROPER PREP OF THE DEVICE FOR USE, OR INTERACTION OF THE STENT WITH ANATOMY OR ACCESSORY DEVICES DURING THE PROCEDURE. UNFORTUNATELY, BASED ON THE CASE INFO AND RETURNED STENT, AND WITHOUT THE RETURN OF THE COMPLETE DEVICE, A DEFINITIVE ROOT CAUSE FOR THE STENT DISLODGEMENT IN THIS CASE COULD NOT BE DETERMINED. THE LOT NUMBER IN THIS INCIDENT IS UNKNOWN BECAUSE THE CATHETER PORTION OF THE STENT DELIVERY SYSTEM WAS NOT RETURNED FOR ANALYSIS AND THE LOT NUMBER WAS NOT REPORTED; HOWEVER, IN THE LAST THREE YEARS, ONLY TWO LOTS OF RX ULTRA WITH THE PART NUMBER OF 1003380 HAVE BEEN MANUFACTURED. THERE WERE NO NON-CONFORMITIES RELATED TO THE REPORTED DEVICE ISSUE IN NEITHER LOT NOR WERE THERE ANY SIMILAR INCIDENTS FOR THE REPORTED STENT DISLODGEMENT IN THIS CASE. HOWEVER, IT SHOULD BE NOTED THAT BOTH OF THESE LOTS WOULD HAVE BEEN EXPIRED AT THE TIME OF USE, BUT SHOULD NOT HAVE CONTRIBUTED TO THE REPORTED DEVICE ISSUE. THE INSTRUCTIONS FOR USE (IFU) DOES INSTRUCT TO VERIFY THE PRODUCT EXPIRATION PRIOR TO USE. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: STENT DISLODGEMENT REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS) DURING USE AND WAS LOST IN THE CORONARY VEIN GRAFT. THE STENT WAS SNARED AND REMOVED OUT OF THE PT'S BODY. POBA WAS PERFORMED TO COMPLETE THE PROCEDURE. REPORTEDLY, THERE WERE NO PT EFFECTS. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF GUIDANT VASCULAR INTERVENTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention