BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 3102946 · Received May 9, 2013

    Report

    Report Number
    2024168-2013-02898
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 16, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL ABSOLUTE PRO REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DIFFICULTIES DEPLOYING THE STENT WERE UNABLE TO BE CONFIRMED. 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. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT FILED, THE ABSOLUTE PRO (LOT # 1111661) WAS RETURNED; HOWEVER, THE STENT WAS NOT DEPLOYED AS REPORTED. THE STENT WAS STATIONARY UNDER THE SHEATH AND THE SHEATH WAS NOT RETRACTED. THE ACCOUNT CONFIRMED THAT THE CORRECT DEVICE WAS RECEIVED; HOWEVER, THE ACCOUNT COULD NOT REMEMBER HOW THE SHAFT WAS BLOCKED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. PRE-DILATATION WAS PERFORMED AND THE 6.0/60 MM ABSOLUTE PRO STENT SYSTEM WAS ADVANCED TO THE LESION. THE THUMBWHEEL WAS ROTATED AND THE PROTECTIVE SHEATH WAS RETRACTED; HOWEVER, THE STENT DID NOT COMPLETELY DEPLOY. THE INTRODUCER SHEATH WAS USED TO DEPLOY THE STENT FROM THE DELIVERY CATHETER INTO THE EXTERNAL ILIAC ARTERY. THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT; HOWEVER, IT WAS REPORTED THAT THE LOCK WAS BLOCKED. THE STENT WAS NOT DEPLOYED IN THE TARGET LESION, BUT WAS DEPLOYED IN ANOTHER LESION THAT WAS PLANNED TO BE TREATED. A NEW 6.0/60 MM ABSOLUTE PRO STENT SYSTEM WAS ADVANCED AND THE THUMBWHEEL WAS ROTATED, BUT THE STENT DID NOT COMPLETELY DEPLOY. THE STENT WAS SUCCESSFULLY RETRIEVED WITH THE INTRODUCER AND REMOVED FROM THE ANATOMY. A NEW STENT WAS USED TO TREAT THE TARGET LESION. THE PATIENT HAD A GOOD OUTCOME. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203416 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 1111661

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT: ABSOLUTE PRO