BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM

    MDR report key: 3180430 · Received June 20, 2013

    Report

    Report Number
    3006982370-2013-05002
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    September 19, 2011
    Report Date
    May 30, 2013
    Manufacturer
    FLEXIBLE STENTING SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K130981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    UPON REVIEW, THIS FILE WAS NOTED TO HAVE ORIGINATED FROM OUR (B)(4) AFFILIATE. THE CORRECTED INFORMATION/INITIAL REPORTER INFORMATION FOR SECTION E IS BELOW: (B)(6).

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE REPORTED EVENT WAS SUBMITTED VIA THE ANNUAL IDE AND NO FURTHER REPORTS WILL BE FORTHCOMING VIA THE 3500A MANUFACTURING REPORT NUMBER ASSOCIATED WITH THIS COMPLAINT FILE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT CATALOG AND LOT NUMBER WERE RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED AN INTIMAL DISSECTION DURING THE INDEX PROCEDURE NECESSITATING ANOTHER STENT FOR TREATMENT. COMPLAINT CONCLUSION: THE REPORT RECEIVED INDICATED THAT THE PATIENT WAS ENROLLED IN A FLEXSTENT EU REGISTRY AND THAT AT THE PATIENT¿S SIX MONTH FOLLOW-UP VISIT A DIAGNOSTIC ULTRASOUND WAS PERFORMED WHICH INDICATED AN OCCLUSION. AN ADDITIONAL INTERVENTION WAS PERFORMED, HOWEVER, IT WAS NOT INDICATED WHAT THE INTERVENTION WAS OR IF THE INTERVENTION WAS PERFORMED AS A RESULT OF THE REPORTED STENT FRACTURE. AT THE TWELVE MONTH FOLLOW-UP, THE PREVIOUSLY IMPLANTED FLEXSTENT WAS NOTED TO BE FRACTURED ON X-RAY. THE FRACTURE WAS REPORTED TO BE A TYPE III AND WAS MID STENT. AN ULTRASOUND PERFORMED INDICATED THAT THERE WAS NO EVIDENCE OF BINARY RESTENOSIS. THE INDEX PROCEDURE BASELINE VISUAL ESTIMATE OF THE LESION LENGTH LOCATED IN THE RIGHT SUPERFICIAL ARTERY WAS REPORTED AS 100MM WITH AN 80% STENOSIS. A 6X120 STENT WAS IMPLANTED FOLLOWED BY A 6X80 STENT IMPLANTED PROXIMALLY TO TREAT A DISSECTION. RESIDUAL STENOSIS POST INDEX PROCEDURE WAS REPORTED AS 20% WITH NO ADDITION COMPLICATIONS. FSS HAS COMPLETED THE REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 1000805 AND THE ASSOCIATED SUBASSEMBLY LOT. ALL ACCEPTANCE CRITERIA WAS MET. BMT ALSO COMPLETED A REVIEW OF THEIR DEVICE HISTORY RECORDS FOR THE MANUFACTURE OF THE SUBASSEMBLY LOT AND THE ASSOCIATED STENT LOT. BMT CONFIRMED THAT THE SUBASSEMBLY AND STENT LOTS WERE MANUFACTURED IN ACCORDANCE WITH THEIR TRAVELER AND ALL ACCEPTANCE CRITERIA WAS MET. THERE ARE MULTIPLE FACTORS THAT CAN CONTRIBUTE TO STENT FRACTURE IN THE SFA. THE SFA IS A VERY DYNAMIC VESSEL THAT UNDERGOES BIOMECHANICAL FORCES SUCH AS FLEXION, TORSION, COMPRESSION, AND ELONGATION. STUDIES HAVE ALSO REVEALED THAT NITINOL STENT FRACTURES OCCURRED IN CASES OF MULTIPLE STENTS AND OVERLAP RELATED TO AN ABNORMAL STRESS AREA THAT IS CREATED. THE CUMULATIVE LENGTH OF THE STENTED SEGMENT UNEQUIVOCALLY HAS BEEN IDENTIFIED AS THE MOST IMPORTANT DETERMINANT FOR MATERIAL FATIGUE AND SUBSEQUENT FRACTURE. THE ANATOMY OF THE SUPERFICIAL FEMORAL ARTERY IS COMPLICATED AND IS LIKELY THE LARGEST CONTRIBUTOR TO STENT FAILURES. EXTRINSIC DYNAMIC FORCES INCLUDING COMPRESSION, TORSION, AND EXPANSION CAN PREDISPOSE STENTS TO FRACTURE AND IN-STENT RESTENOSIS. IN THIS CASE, VESSEL/LESION CHARACTERISTICS, PROCEDURAL FACTORS AND/OR BIOMECHANICAL FORCES LIKELY CONTRIBUTED TO THE REPORTED EVENT. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THIS DOES NOT REPRESENT DEVICE MALFUNCTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL / LESION CHARACTERISTICS AND POSSIBLY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT THE PATIENT WAS ENROLLED IN A (B)(6) REGISTRY AND THAT AT THE TWELVE MONTH FOLLOW-UP, THE PREVIOUSLY IMPLANTED FLEXSTENT WAS NOTED TO BE FRACTURED ON X-RAY. THE FRACTURE WAS REPORTED TO BE A TYPE III AND WAS MID STENT. AN ULTRASOUND PERFORMED INDICATED THAT THERE WAS NO EVIDENCE OF BINARY RESTENOSIS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279877 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE FLEXIBLE STENTING SOLUTIONS 1000805

    Patients

    Seq Age Sex Outcome Treatment
    1