BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 1912004 · Received December 1, 2010

    Report

    Report Number
    3004742046-2010-00568
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE: TERUMO; SHEATH: 6FR CROSS-OVER. THE INVESTIGATION IS NOT COMPLETE. FOLLOW UP REPORT WILL BE FILED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). FACTORS THAT MAY CONTRIBUTE TO STENT DAMAGE INCLUDE, BUT ARE NOT LIMITED TO, DAMAGED DURING MANUFACTURING, DAMAGED DURING REMOVAL FROM PACKAGING, DAMAGED DURING REMOVAL OF THE TIP MANDREL, DAMAGED DURING PREPARATION OR DURING USE DUE TO ANATOMICAL CONDITIONS. DURING MANUFACTURING ALL SELF EXPANDING STENT SYSTEMS (SESS) ARE 100% VISUALLY INSPECTED FOR DAMAGE AT MULTIPLE OPERATIONS PRIOR TO LOADING INTO THE DISPENSER COIL AND PACKAGING. THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. IN THIS CASE, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT WHEN LOOKING AT THE IMAGES THE STENT WAS NOT FRACTURED; HOWEVER, APPEARED TO BE FLARED. IT IS POSSIBLE THAT THE STENT MAY HAVE APPEARED TO BE FLARED DUE TO THE ANATOMICAL CONDITIONS, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED FLARED STENT AND SUBSEQUENTLY RESULTED IN THE ADDITIONAL STENTING (ADDITIONAL THERAPY/ NON SURGICAL TREATMENT). ALTHOUGH A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED FLARED STENT, THE ADDITIONAL STENTING (ADDITIONAL THERAPY/ NON SURGICAL TREATMENT) APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MILDLY CALCIFIED/TORTUOUS MID SUPERFICIAL FEMORAL ARTERY, AN ABSOLUTE PRO STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. POST DILATATION WAS PERFORMED USING A FOXCROSS DILATATION CATHETER. THE BALLOON WAS INFLATED ONE TIME AT 12 ATMOSPHERES. IMMEDIATELY AFTER POST-DILATATION, THE PHYSICIAN OBSERVED THAT THE STENT WAS FLARED. A JOSTENT WAS DEPLOYED AT THE LOCATION OF THE FLARED STENT WITH GOOD RESULTS. THERE WAS NO ADVERSE PATIENT EFFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) FOLFUSOR LV5 DEVICE HAD OVERINFUSED DURING PATIENT USE. THE DEVICE WAS FILLED WITH 2700 MG OF 5-FLUOROURACIL (5-FU), 400 MG SODIUM-FOLINAT AND 250 ML OF 0.9% SODIUM CHLORIDE. THE DEVICE WAS CONNECTED TO THE PATIENT ON (B)(6) 2010 AT 12:45 PM. IN THE EVENING OF (B)(6) 2010, THE DEVICE WAS CHECKED TO BE PERFORMING OK. AT 8:00 AM ON (B)(6) 2010, THE PATIENT OBSERVED THE DEVICE TO BE EMPTY (TOTAL INFUSION TIME OF 43.25 HOURS WHEREAS EXPECTED IS 48 HOURS). AROUND 2:00 PM (B)(6) 2010, THE PATIENT SUFFERED FROM NAUSEA, SWEATING, AND PAIN (BURNING) IN THE LOWER ABDOMEN. DURING THE EVENING OF (B)(6) 2010, THE PATIENT DRANK MORE LIQUID THAN USUAL AND THEN TOOK A PAIN KILLER IN THE MORNING OF (B)(6) 2010. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM FGE AV-TEMECULA 806305Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIL CATH: FOXCROSS 8X40