BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING STENT SYSTEM

    MDR report key: 2250181 · Received September 15, 2011

    Report

    Report Number
    2024168-2011-06328
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED SELF EXPANDING STENT SYSTEM (SESS) FOUND BLOOD ON THE STENT IMPLANT. THERE WAS SALINE IN THE OUTER TUBE. THE STENT IMPLANT WAS PARTIALLY EXPANDED ON THE FIRST FOUR ROWS OF STRUTS, CONSISTENT WITH THE REPORTED INFORMATION. THE DISTAL END OF THE STENT IMPLANT WAS AT THE DISTAL END OF THE TIP; THE PROXIMAL END OF THE STENT IMPLANT WAS 3 MM DISTAL TO THE PROXIMAL MARKER BAND. THE OUTER TUBE WAS 1.1 CM PROXIMAL TO THE PROXIMAL END OF THE TIP. THE OUTER TUBE WAS BUNCHED DISTAL TO THE STRAIN RELIEF TUBING FOR A LENGTH OF 6 MM. THE OUTER TUBE WAS WRINKLED 2.2 CM, 2.5 CM 3CM AND 11.6 CM DISTAL TO THE STRAIN RELIEF TUBING. THE METAL SHAFT WAS KINKED 4 CM AND 4.5 CM DISTAL TO THE LUER. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE TUOHY BORST ADAPTER WAS TIGHT ON THE METAL SHAFT. THERE WAS NO OTHER DAMAGE NOTED TO THE SESS. POTENTIAL FACTORS FOR DIFFICULTY DEPLOYING INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, PRE DILATATION STRATEGY, ANATOMICAL CONDITIONS, DEPLOYMENT TECHNIQUE, KINKS OR CHATTER MARKS IN THE SHAFT AND/OR DAMAGE TO THE DEVICE DEPLOYMENT MECHANISMS (HANDLE COMPONENTS/SHAFT LUMENS). IN THIS CASE, IT IS POSSIBLE THAT THE ANATOMICAL CONDITIONS CONTRIBUTED TO THE DIFFICULTY, AS THE LESION SITE WAS REPORTED TO BE TOTALLY OCCLUDED. IT MAY BE POSSIBLE THAT THE DISTAL END OF THE OUTER MEMBER BECAME ENTRAPPED WITH THE ANATOMY CAUSING THE SHAFT TO BUNCH AND WRINKLE AND THE METAL SHAFT TO BEND DURING THE ATTEMPT TO DEPLOY. ADDITIONALLY, THE PARTIAL DEPLOYMENT APPEARS TO BE THE RESULT OF BUILT UP FRICTION WITHIN THE OUTER SHEATH AFTER FAILING TO DEPLOY, AND ONCE THE DELIVERY SYSTEM WAS PULLED OUT OF THE ENTRAPPED STATE INTO THE SHEATH, THE STENT BEGAN TO DEPLOY. BASED ON THE REPORTED INFORMATION AND RETURNED DEVICE ANALYSIS, IT IS LIKELY THAT ANATOMICAL CONDITIONS CONTRIBUTED TO THE REPORTED DIFFICULTIES. THERE WAS NO ASSOCIATED NONCONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. ADDITIONALLY, THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: POINTER. SHEATH: 4F BIOTRONIK FORTRESS. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY WITH TOTAL OCCLUSION. THE XPERT STENT WAS ADVANCED VIA BRACHIAL ACCESS WITH A 4 FRENCH NON-ABBOTT INTRODUCER SHEATH. THE STENT COULD NOT BE DEPLOYED IN THE TARGET LESION BECAUSE THE RETRACTABLE OUTER SHEATH COULD NOT BE RETRACTED. THE DEVICE WAS REMOVED THROUGH THE 4 FRENCH NON-ABBOTT INTRODUCER SHEATH AND DURING RETRACTION INSIDE THE SHEATH, THE FIRST STRUTS OF THE STENT BECAME SLIGHTLY DEPLOYED. A NEW XPERT DEVICE (SAME SIZE) WAS SUCCESSFULLY USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING STENT SYSTEM SELF-EXPANDING STENT AND DELIVERY SYSTEM FGE AV-TEMECULA-CT 708335

    Patients

    Seq Age Sex Outcome Treatment
    1