BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS AMIIA

    MDR report key: 1842898 · Received September 23, 2010

    Report

    Report Number
    9610978-2010-00184
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL REPORT RECEIVED FROM THE AFFILIATE STATED THAT WHEN THE PHYSICIAN TRIED TO ADVANCE THE PALMAZ GENESIS SDS RX 7.0X24 142CM STENT, HE FELT RESISTANCE FROM THE DISTAL TIP. THE PHYSICIAN FOUND THE TIP WAS KINKED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN THEN TREATED THE LESION WITH A NEW GENESIS STENT. THERE WAS NO PATIENT INJURY REPORTED. A PRODUCT WAS RECEIVED FOR EVALUATION AND DURING PRELIMINARY ANALYSIS, IT WAS NOTED THAT THERE WAS A POSSIBLE SECONDARY FAILURE. IT WAS NOTED THAT THE STENT WAS NOT MOUNTED ON THE BALLOON OF THE RETURNED SDS. THE EVENT WAS REPORTED AS IT WAS THOUGHT THAT THE STENT HAD DISLODGED SOMETIME DURING USE, UP UNTIL THE TIME THE PRODUCT WAS RETURNED. THERE WAS NO INFORMATION AS TO WHEN THE EVENT HAD OCCURRED AS THE SALES REP ASSOCIATED WITH THIS ACCOUNT WAS NO LONGER EMPLOYED WITH THIS COMPANY (CORDIS). DURING EVALUATION, IT WAS ALSO FOUND THAT THE RETURNED PRODUCT DID NOT MATCH THE PRODUCT LISTED IN THE COMPLAINT. THE REPORTED COMPLAINT PRODUCT WAS A PALMAZ GENESIS AMIIA (PG2470PMW/ LOT R1008290). ON THE SHAFT OF THE RECEIVED DEVICE A "4X30" WAS NOTED. IT WAS FOUND THAT THE PRODUCT RECEIVED WAS AN AMIIA 4.0X30 142CM PTA BALLOON (4234030W/ LOT UNKNOWN), WHICH DOES NOT HAVE A STENT MOUNTED ON IT (NOT A STENT DELIVERY SYSTEM). THE PALMAZ GENESIS AMIIA (PG2470PMW/ LOT R1008290) WAS NEVER RETURNED FOR EVALUATION AND TESTING. SINCE THERE WAS NEVER A REPORT OF STENT DISLODGEMENT IN THE INITIAL REPORT, JUST THAT THE TIP KINKED, THE EVENT OF STENT DISLODGEMENT IS BEING UNREPORTED. THEREFORE, THIS EVENT OF STENT DISLODGEMENT IS NO LONGER CONSIDERED REPORTABLE AS THERE WAS NEVER A REPORT OF THE MALFUNCTION AND THE ACTUAL PRODUCT WAS NEVER RETURNED. PLEASE UPDATE YOUR FILES ACCORDINGLY. NO ADDITIONAL FOLLOW-UP WILL BE FORTHCOMING FOR THE PALMAZ GENESIS AMIIA STENT DELIVERY SYSTEM STENT DISLODGEMENT. AN ANALYSIS WAS COMPLETED ON THE RETURNED AMIIA PTA BALLOON AND IT WAS NOTED THAT "THE PRODUCT'S TIP PRESENTS A PUNCTURE AND KINK DAMAGES." THE PUNCTURED TIP DOES MEET THE CRITERIA OF A REPORTABLE PRODUCT MALFUNCTION AND WILL BE REPORTED IN A SEPARATE MEDWATCH REPORT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORT # 9610978-2010-00184 AND 9610978-2010-00233.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED BUT THE REPORTER IS LONGER WITH THE COMPANY AND NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE ORIGINAL REPORT RECEIVED FROM THE AFFILIATE STATES THAT WHEN THE PHYSICIAN TRIED TO ADVANCE THE GENESIS SDS RX GEN. AMIIA 7.0X24 142CM STENT, HE FELT RESISTANCE FROM THE DISTAL TIP. HE FOUND OUT THE TIP WAS KINKED. THE PHYSICIAN THEN TREATED THE LESION WITH NEW GENESIS STENT. THERE WAS NO PATIENT INJURY REPORTED. A PRODUCT WAS RECEIVED FOR EVALUATION AND IT WAS NOTED THAT A SECONDARY FAILURE WAS DISCOVERED. STENT IS DETACHED AND NOT INCLUDED. THE SHAFT OF THIS DEVICE ALSO STATES 4X30. THE REPORTED PRODUCT WAS A PALMAZ GENESIS AMIIA (7.0X24X142).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS AMIIA ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA R1008290

    Patients

    Seq Age Sex Outcome Treatment
    1