BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM

    MDR report key: 2874493 · Received December 14, 2012

    Report

    Report Number
    2024168-2012-07979
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    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. THE SHEATH AND STENT WERE REMOVED TOGETHER LEAVING THE SECOND STENT FRAGMENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WILL BE REVIEWED FOR FURTHER INTERVENTIONAL PROCEDURES LATER IN THE WEEK. THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT WAS ADMINISTERED ADDITIONAL HEPARIN. NO ADDITIONAL INFORMATION WAS PROVIDED. GUIDE WIRE: TERUMO LONG STIFF GLIDE WIRE; SHEATH: CORDIS 6F BRITE TIP 55CM X2; OTHER: HEPARIN. (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT SEPARATION WAS ABLE TO BE CONFIRMED. THE DIFFICULTIES DEPLOYING THE STENT AND RETRACTION PROBLEM COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. BASED ON A VISUAL ANALYSIS 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. THE ADDITIONAL ABSOLUTE PRO REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: IMAGES FROM THE PROCEDURE WERE RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER NOTED THERE IS A STENT FRAGMENT IN THE LEFT ILIAC WITH DISTAL MARKERS AND NO PROXIMAL MARKERS VISIBLE. THERE IS A SECOND STENT POSITIONED PROXIMALLY AND ADJACENT TO OR OVERLAPPING THIS STENT FRAGMENT. THE PROXIMAL EDGES OF THIS STENT ARE NOT VISIBLE. THIS REVIEWER CANNOT CONFIRM THAT THIS STENT IS PARTIALLY SHEATHED. AN EXPANDED STENT IS SHOWN ON A 4X4 GAUZE. ONE END OF THE STENT IS STRETCHED WITH STENT FRACTURES. THE REVIEWER CONCLUDED THAT THOUGH THE IMAGES CANNOT CONFIRM THE INCIDENT DESCRIPTION, THEY ARE CONSISTENT WITH STENT DAMAGE AND STENT SEPARATION/FRAGMENTATION. IT SHOULD BE NOTED THE ABSOLUTE PRO LONG LENGTH (LL) SELF EXPANDING STENT SYSTEM INSTRUCTIONS FOR USE STATES: DO NOT ATTEMPT TO PULL A PARTIALLY EXPANDED STENT BACK THROUGH THE SHEATH OR GUIDING CATHETER; DISLODGEMENT OF THE STENT FROM THE DELIVERY SYSTEM MAY OCCUR. ONCE THE STENT HAS STARTED TO DEPLOY, IT IS NOT RECOMMENDED TO REMOVE THE STENT WITH THE DELIVERY SYSTEM. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MILDLY TORTUOUS, HEAVILY CALCIFIED, RESTENOSED, SUPERFICIAL FEMORAL ARTERY (SFA) BELOW A BIFURCATION, A 5 X 100 MM FOXCROSS BALLOON DILATATION CATHETER (BDC) WAS USED FOR PREDILATATION OF THE DIFFICULT TO CROSS LESION TAKING ABOUT 1 HOUR. THE 6.0 X 150 MM ABSOLUTE PRO STENT DELIVERY SYSTEM (SDS) WAS DELIVERED TO THE SITE BUT AS THE STENT WAS BEING DEPLOYED, ONLY ABOUT 2 CM OPENED; THE THUMBWHEEL TURNED BUT THE SHEATH DID NOT RETRACT. THE HANDLE WAS OPENED TO MANUALLY DEPLOY THE STENT WITHOUT SUCCESS. IT WAS NOTED THAT THE PHYSICIAN ATTEMPTED TO PULL THE STENT BACK INTO THE SHEATH, HOWEVER, THE DEPLOYED SECTION BECAME STUCK. A SECOND PULLING FRACTURED THE STENT LEAVING APPROXIMATELY A 2-3 CM SECTION IN THE LEFT COMMON ILIAC ARTERY. A SECOND 6.0 X 120 MM ABSOLUTE PRO SDS WAS POSITIONED AT THE SITE OF THE INITIAL STENOSIS. THE THUMBWHEEL WAS TURNED BUT THE STENT DID NOT DEPLOY. THE HANDLE WAS OPENED TO MANUALLY ATTEMPT DEPLOYMENT WITHOUT SUCCESS. IT APPEARED UNDER ANGIOGRAPHY THAT THE STENT HAD NOT DEPLOYED AT ALL. THE SECOND SDS WAS BEING REMOVED WHEN IT MET RESISTANCE AND WAS CAUGHT ON THE FIRST STENT FRAGMENT IN THE ILIAC ARTERY AND ABOUT 3 CM OF THE STENT DEPLOYED. AS THE SDS WAS RETRACTED THE STENT DEPLOYED FURTHER NOW AT THE ILIAC ARCH. SURGERY WAS CONSIDERED, HOWEVER, THE PHYSICIAN USED A BALLOON DILATATION CATHETER INFLATED INSIDE THE STENT TO BRACE IT AGAINST THE WALL OF THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA-CT 1100851

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R