BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 1884057 · Received October 27, 2010

    Report

    Report Number
    9610978-2010-00216
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    September 9, 2010
    Report Date
    December 6, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    ORIGINAL REPORT RECEIVED WAS THAT THE STENT DELIVERY SYSTEM KINKED DURING PREPARATION OF THE DEVICE. AS REPORTED, THE DEVICE WAS NOT INTRODUCED INTO THE PATIENT BECAUSE THE SURGEON DETECTED THAT THE CATHETER WAS KINKED (LIKE CREASED) WHEN HE INTRODUCED IT THROUGH ITS INTRODUCER. A SECONDARY FAILURE WAS NOTED WHEN THE DEVICE WAS RECEIVED. THE PROXIMAL STENT STRUTS WERE FLARED. THE AFFILIATE COULD NOT CONFIRM IF THIS WAS PART OF THE INITIAL COMPLAINT OR IF IT OCCURRED DURING SHIPMENT OF THE DEVICE. THE DEVICE WAS NOT USED IN THE PATIENT. ALSO NOTED DURING ANALYSIS WAS A FOREIGN MATERIAL ATTACHED TO THE HOOK OF THE FILTER. ANALYSIS SHOWS THAT ITS COMPOSITION IS BIOLOGICAL. IT IS UNKNOWN WHERE THIS MATERIAL ORIGINATED FROM. A NON STERILE PG ON OPTA PRO 7.0MM X 59 MM, 80 CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE PRODUCT WAS RECEIVED WITHIN AN UNKNOWN SHEATH INTRODUCER; THE SHEATH INTRODUCER PRESENTS A KINK AT 4.7CM FROM THE DISTAL TIP. THE BALLOON AND STENT WERE NOT EXPANDED, BUT THE STENT IS FLARED AT THE PROXIMAL END AND IT HAS AN UNKNOWN RESIDUES. NO KINKS WERE NOTED IN THE SHAFT PRODUCT OR TIP. UNKNOWN RESIDUES OBSERVED AT THE STENT WERE ANALYZED BY FOURIER TRANSFORM INFRARED SPECTROSCOPY (FT-IR) AND IT WAS CONCLUDED THAT FOREIGN MATERIAL HAS BIOLOGICAL COMPOSITION SIMILAR TO THAT FOUND ON HUMAN TISSUE. (B)(4). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE DISTAL TIP KINKED/BENT FAILURE REPORTED BY THE CUSTOMER WAS NOT CONFIRMED SINCE NO KINKS WERE NOTED IN THE SHAFT AND DISTAL TIP, THE KINKED SHEATH INTRODUCER WAS NOT MANUFACTURED AT CORDIS; FOR THE STENT FLARED SECONDARY FAILURE REPORTED, THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, IT IS LIKELY THE PROCEDURAL FACTOR COULD CONTRIBUTE WITH THE REPORTED FAILURE SINCE NO ANOMALIES WERE NOTED WHEN THE UNIT WAS REMOVED FROM ITS PACKAGING. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURES EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. CONTROLS ARE IN PLACE TO INSPECT THE STENT PLACEMENT AND ANOMALIES BEFORE IT LEAVES THE FACILITY. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY THE OPERATIONAL CONTEXT OF THE DEVICE AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 1

    THE GENESIS 7X59MM 80CM PRO STENT DELIVERY SYSTEM KINKED DURING PREP. A SECONDARY FAILURE WAS NOTED WHEN THE DEVICE WAS RECEIVED. THE PROXIMAL STENT STRUTS WERE FLARED. THE AFFILIATE COULD NOT CONFIRM IF THIS WAS PART OF THE INITIAL COMPLAINT OR IF IT OCCURRED DURING SHIPMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA 15114273

    Patients

    Seq Age Sex Outcome Treatment
    1