BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 3901937 · Received May 28, 2014

    Report

    Report Number
    9681442-2014-00087
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE U.S., THIS EVENT IS BEING REPORTED UNDER REGULATION 21CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE U.S. UNDER #(B)(4). THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THERE IS NO INDICATION FOR A MANUFACTURING-RELATED FAILURE. AS PART OF ALL COMPLAINT INVESTIGATIONS, AN ATTEMPT WAS MADE TO EVALUATE THE SUBJECT DEVICE AS WELL AS THE DEVICE USAGE. IN THIS CASE, NO SAMPLE WAS RETURNED. A DIGITAL IMAGE WAS PROVIDED. HOWEVER, ON THE IMAGE THE LENGTH OF THE IMPLANTED STENT COULD NOT BE DETERMINED AND ALLEGED STENT ELONGATION COULD NOT BE CONFIRMED. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN EVALUATED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. AN UNINTENDED MOVEMENT OF THE DELIVERY SYSTEM DURING DEPLOYMENT MAY RESULT IN A STRETCHED STENT. ALSO AN EXCESSIVE COMPRESSION OF THE OUTER CATHETER DURING DEPLOYMENT OR INCORRECT HOLDING OF THE SYSTEM MAY CAUSE AN INACCURATE STENT DEPLOYMENT AND SUBSEQUENT STENT ELONGATION. ALSO A CHALLENGING PLACEMENT, TORTUOUS OR CALCIFIED VESSELS AS WELL AS NOT PERFORMED PRE-DILATION MAY BE CONTRIBUTING FACTORS. NO PROCEDURAL DETAILS HAVE BEEN PROVIDED. BASED ON THE INFO AVAILABLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VASCULAR STENT IMPLANTED IN THE SFA APPEARED TO BE LONGER THAN EXPECTED DURING X-RAY EXAMINATION. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315003 LIFESTENT VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANX12544

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR