BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS AMIIA

    MDR report key: 2468905 · Received February 27, 2012

    Report

    Report Number
    9616099-2012-00119
    Event Type
    Injury
    Date Received
    February 27, 2012
    Date of Event
    January 26, 2012
    Report Date
    February 16, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.CONCOMITANT PRODUCTS: 4X19 EXPRESS SD (BSJ), 3X20 STERLING (BSJ).

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED STATES THAT WHEN ATTEMPTING TO DEPLOY A STENT IN THE LEFT RENAL ARTERY WITH MILD CALCIFICATION AND VESSEL TORTUOSITY AND A STENOSIS OF 90% THE BALLOON OF THE STENT DELIVERY SYSTEM DID NOT EXPAND EVENLY, CAUSING THE STENT TO SLIP OFF OF THE BALLOON AND LAND 10MM DISTAL TO THE TARGET POSITION. AN ADDITIONAL PALMAZ GENESIS STENT WAS PLACED AT PROXIMAL SIDE AND THE ENTIRE TARGET LESION WAS FULLY COVERED. THE BRAND OF CONTRAST AND THE CONTRAST TO SALINE RATIO USED TO INFLATE THE BALLOON IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY DIFFICULTY TRACKING THE SDS THROUGH THE VESSEL OR CROSSING THE LESION WITH THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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 EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED MAY HAVE BEEN CAUSED BY THE PROCEDURAL FACTORS OR OPERATIONAL CONTEXT OF THE DEVICE AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT WHEN ATTEMPTING TO STENT THE TARGET LESION THE BALLOON OF THE STENT DELIVERY SYSTEM DID NOT EXPAND EVENLY, CAUSING THE STENT TO SLIP OFF THE BALLOON AND BE PLACED IN AN UNINTENDED LOCATION IN THE VESSEL. THE PATIENT'S GENDER AND AGE WERE UNKNOWN. THE TARGET LESIONS WERE BOTH RENAL ARTERIES (RA). MILD CALCIFICATION AND VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 90%. THE TARGET LESION WAS 15MM LONG, STARTING FROM 5MM DISTAL TO THE OSTIAL OF THE RA. APPROACH WAS MADE FROM THE LEFT BRACHIAL ARTERY. THE RIGHT RA LESION WAS TREATED BY PLACING 4X19 EXPRESS SD (BSJ). AFTER THE LEFT RA LESION WAS DILATED WITH 3X20 STERLING (BSJ), A PALMAZ GENESIS (COMPLAINT PRODUCT) WAS DELIVERED TO THE LEFT RA LESION. HOWEVER, THE BALLOON STARTED TO EXPAND UNEVENLY FROM THE PROXIMAL SIDE DURING THE INFLATION. THEREFORE, THE STENT SLIPPED DISTALLY AND WAS PLACED 10MM DISTAL TO THE TARGET POSITION. AN ADDITIONAL STENT, 5X18 PALMAZ GENESIS (LOT UNK) WAS PLACED AT PROXIMAL SIDE AND THE ENTIRE TARGET LESION WAS FULLY COVERED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. THE PRODUCTS WERE PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THE BRAND OF INFLATION DEVICE USED IN THE PROCEDURE IS UNKNOWN. THE BRAND OF CONTRAST USED TO INFLATE THE BALLOON IS UNKNOWN. THE CONTRAST TO SALINE RATIO IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY DIFFICULTY TRACKING THE SDS THROUGH THE VESSEL OR CROSSING THE LESION WITH THE BALLOON. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS AMIIA ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA 15282252

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R