BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 1984338 · Received February 10, 2011

    Report

    Report Number
    2024168-2011-00809
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - BILIARY STENT USED IN THE PERIPHERY. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS NOT RETURNED FOR AN EVALUATION. POTENTIAL CAUSES FOR TIP DETACHMENT DURING USE INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, TIP BECOMING ENTRAPPED WITHIN THE LESION, MISHANDLING DURING LOADING ONTO A GUIDE WIRE, INTERACTION WITH THE STENT STRUTS POST DEPLOYMENT OR INTERACTIONS WITH THE INTRODUCER SHEATH AND/OR ASSOCIATED DEVICES DURING INSERTION. TO ENSURE THIS IS NOT RESULT OF A MANUFACTURING DEFICIENCY, 100% OF THE TIPS ARE INSPECTED DURING LOADING OF THE MANDREL ON THE MANUFACTURING LINE. ADDITIONALLY A TIP PULL TEST IS PERFORMED DURING RELIABILITY TESTING ON-LINE. BASED ON THE REPORTED INFORMATION, IT MAY BE POSSIBLE THAT THE TIP CAUGHT ON THE STENT STRUTS POST-DEPLOYMENT AND DURING REMOVAL, THE TIP SEPARATED. HOWEVER, THIS COULD NOT BE CONFIRMED. IT SHOULD BE NOTED THAT THE INSTRUCTION FOR USE (IFU) STATES: THE ABSOLUTE .035 BILIARY SELF-EXPANDING STENT SYSTEM IS INTENDED FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE. IN THIS CASE, IT CAN NOT BE DETERMINED IF THE OFF-LABEL USE IN THE SFA CONTRIBUTED TO THE REPORTED EVENT. OVERALL, A CONCLUSIVE CAUSE FOR THE REPORTED TIP DETACHMENT COULD NOT BE DETERMINED. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO A DISSECTION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (RSFA), AN ABSOLUTE STENT WAS DEPLOYED. AFTER REMOVAL OF THE ABSOLUTE STENT DELIVERY SYSTEM (SDS), IT WAS NOTED THAT THE TIP OF THE SDS WAS MISSING. PER ANGIOGRAM, THE TIP WAS SEEN DISTAL TO THE STENT IN THE SFA. A NON-ABBOTT DISTAL PROTECTION DEVICE WAS PLACED DISTAL TO THE TIP AND A NON-ABBOTT CATHETER WAS PLACED PROXIMAL TO THE TIP SANDWICHING THE TIP. THE DISTAL PROTECTION DEVICE, CATHETER AND WIRE WERE REMOVED AS ONE UNIT, PULLING THE TIP OUT OF THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE .035 SELF EXPANDING STENT SYSTEM SELF-EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 0090261

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention ATHERECTOMY: ANGIOSCOPE BALLOON