BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PALMAZ STENT

    MDR report key: 8039279 · Received November 5, 2018

    Report

    Report Number
    9616099-2018-02492
    Event Type
    Injury
    Date Received
    November 5, 2018
    Date of Event
    July 1, 1998
    Report Date
    November 5, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SHANNON, H. M., GILLESPIE, I. N., & MOSS, J. G. (1998). SALVAGE OF THE SOLITARY KIDNEY BY INSERTION OF A RENAL ARTERY STENT. AMERICAN JOURNAL OF ROENTGENOLOGY, 171(1), 217-222. DOI:10.2214/AJR.171.1.9648792. THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICES ARE PALMAZ STENT BUT THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. AS NOTED IN THE PUBLICATION BY SHANNON ET AL SALVAGE OF THE SOLITARY KIDNEY BY INSERTION OF A RENAL ARTERY STENT, AJR AM J ROENTGENOL. 1998 JUL;171(1):217-22; ONE STENT WAS INADVERTENTLY MOUNTED ON A HYDROPHILIC BALLOON AND SLID DISTALLY OFF THE BALLOON DURING INFLATION. THE STENT LODGED IN THE DISTAL RENAL CIRCULATION AND WAS RETRIEVED BY MEANS OF A NON-CORDIS GOOSENECK SNARE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿STENT DISLODGED - IN PATIENT¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS NOR WERE IMAGES PROVIDED FOR REVIEW. THE EXACT CAUSE COULD NOT BE DETERMINED. PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT AS THE HYDROPHILIC BALLOON USED AS THE DELIVERY SYSTEM IS LIKELY MORE SLIPPERY DUE TO THE HYDROPHILIC COATING THUS RESULTING IN THE DISLODGEMENT OF THE STENT. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿WARNINGS/PRECAUTIONS WHEN USING THE POWERFLEX PLUS BALLOON CATHETER, USE THE CRIMPING TUBE THAT IS PACKAGED WITH THE BALLOON CATHETER. WHEN USING THE MAXI DS BALLOON CATHETER, USE THE CRIMPING TUBE SUPPLIED WITH THE STENT.¿ ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION OF RISK ¿NOTE: USE THE CRIMPING TUBE, PACKAGED WITH THE BALLOON CATHETER, WHEN USING THE POWERFLEX PLUS BALLOON CATHETER. REMOVE THE CRIMPING TUBE FROM THE SHAFT OF THE POWERFLEX PLUS CATHETER.¿ NEITHER THE PHR NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY SHANNON ET AL SALVAGE OF THE SOLITARY KIDNEY BY INSERTION OF A RENAL ARTERY STENT, AJR AM J ROENTGENOL. 1998 JUL;171(1):217-22; ONE STENT WAS INADVERTENTLY MOUNTED ON A HYDROPHILIC BALLOON AND SLID DISTALLY OFF THE BALLOON DURING INFLATION. THE STENT LODGED IN THE DISTAL RENAL CIRCULATION AND WAS RETRIEVED BY MEANS OF AN AMPLATZ (MICROVENA, WHITE BEAR LAKE, MN) GOOSENECK SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877841 UNKNOWN PALMAZ STENT CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CASHEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R