BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 3122749 · Received May 21, 2013

    Report

    Report Number
    2024168-2013-03206
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE KINK WAS ABLE TO BE CONFIRMED. THE PREMATURE DEPLOYMENT, PHYSICAL RESISTANCE, AND DEVICE OPERATING DIFFERENTLY COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THE ABSOLUTE PERIPHERAL SELF EXPANDING STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: INSPECT ALL PRODUCT PRIOR TO USE. DO NOT USE IF THE PACKAGE IS OPEN OR DAMAGED, OR IF THE PRODUCT IS DAMAGED. AVOID UNNECESSARY HANDLING, WHICH MAY KINK OR DAMAGE THE DELIVERY SYSTEM. FURTHERMORE, IT WAS NOTED THAT THE SESS WAS ADVANCED IN THE PATIENT ANATOMY AS RESISTANCE WAS ENCOUNTERED AT THE BIFURCATION. THE IFU STATES: SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING LESION OR STRICTURE ACCESS OR DELIVERY SYSTEM REMOVAL, THE INTRODUCER SHEATH / GUIDING CATHETER AND STENT SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND DELIVERY SYSTEM COMPONENTS. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE RIGHT ILIAC ARTERY THE ABSOLUTE STENT DELIVERY SYSTEM (SDS) WAS USED AND THE DEVICE DID NOT PERFORM IN AN UNSPECIFIED MANNER. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. A SECOND ABSOLUTE WAS USED IN THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT INFORMATION WAS RECEIVED WHICH STATES THAT DURING PREP, A SLIGHT KINK WAS NOTED WHERE THE CATHETER MEETS THE HANDLE, BUT IT WAS SMOOTHED OUT AND INSERTED INTO THE PATIENT. DURING THE PROCEDURE THE ABSOLUTE SDS WAS USED IN THE ANATOMY AND MET RESISTANCE; BEFORE REACHING THE TARGET LESION ANOTHER INJECTION OF CONTRAST WAS MADE AND THE PHYSICIAN NOTED THAT THE STENT HAD DEPLOYED WITHOUT THE HANDLE BEING UNLOCKED. IT WAS NOTED UNDER FLUOROSCOPY THAT THE STENT WAS BUNCHED IN THE ARTERY. A SECOND LONGER STENT WAS USED TO COVER THE DEPLOYED STENT AND TO STENT THE LESION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224819 ABSOLUTE .035 SELF EXPANDING STENT SYSTEM SELF-EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 2011661

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention