BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 2792536 · Received October 16, 2012

    Report

    Report Number
    9616099-2012-00588
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 25, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K012590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT ALTHOUGH THIS IS A CORRECTION TO THE ALERT DATE, EVEN WITH THE CORRECTION, THE PRIOR 3500A SUPPLEMENTAL MEDWATCH REPORT WAS SUBMITTED ON TIME.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: ((B)(4) 2012) AS IT WAS REPORTED WHILE DELIVERING A PALMAZ GENESIS STENT TO THE RIGHT COMMON ILIAC ARTERY THE STENT EMBOLIZED AT THE AORTA-ILIAC BIFURCATION AND COULD NOT BE RETRIEVED. ACCESS WAS VIA THE LEFT FEMORAL ARTERY. THE PHYSICIAN DEPLOYED AN ADDITIONAL STENT AT THE BIFURCATION TO TRAP THE EMBOLIZED STENT AND CRUSH IT INTO THE ARTERIAL WALL. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. 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. REVIEW OF LOT 15627614 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    AS IT WAS REPORTED, DURING A PROCEDURE, A PALMAZ GENESIS STENT EMBOLIZED. ACCESS VIA THE LEFT FEMORAL ARTERY WAS USED TO TREAT TARGET LESION, RIGHT COMMON ILIAC ARTERY. PALMAZ GENESIS STENT EMBOLIZED WHILE DELIVERING TO LESION AT AORTA ILIAC BIFURCATION. COULD NOT RETRIEVE STENT. PHYSICIAN DEPLOYED PG3910BPX (GENESIS STENT) AND A LIFE STENT AT BIFURCATION WAS USED TO TRAP THE EMBOLIZED STENT AND CRUSH INTO WALL. PATIENT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA 15627614

    Patients

    Seq Age Sex Outcome Treatment
    1