BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PALMAZ STENT

    MDR report key: 8038032 · Received November 5, 2018

    Report

    Report Number
    9616099-2018-02491
    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; TWO STENTS WERE PLACED SLIGHTLY TOO FAR DISTALLY AND FAILED TO COVER THE OSTIAL LESIONS. IN EACH CASE, A SECOND OVERLAPPING STENT WAS DEPLOYED MORE PROXIMALLY WITH SATISFACTORY RESULT. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. NO LOT NUMBERS WERE PROVIDED; THEREFORE, PRODUCT HISTORY RECORD (PHR) REVIEWS COULD NOT BE GENERATED. THE REPORTED ¿STENT INACCURATE PLACEMENT¿ COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR ANALYSIS NOR WERE IMAGES PROVIDED FOR REVIEW. THE EXACT CAUSE COULD NOT BE DETERMINED. PROCEDURAL FACTORS SUCH AS LACKING EXPERIENCE IN INTERVENING IN OSTIAL LESIONS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. PER THE ARTICLE ¿THESE TWO CASES OCCURRED IN THE EARLY STAGES OF THE STUDY, AND AS A RESULT OF THESE EXPERIENCES WE NOW DELIBERATELY TRY TO PLACE STENTS TO PROJECT 1-3MM INTO THE AORTIC LUMEN. FEARS HAVE BEEN EXPRESSED THAT THIS PRACTICE COULD GIVE RISE TO THROMBUS FORMATION AROUND THE EXPOSED STENT, BUT NO SUCH COMPLICATION HAS OCCURRED IN OUR PATIENT GROUP.¿ ACCORDING TO THE INSTRUCTIONS FOR USE, ALTHOUGH THIS IS NOT INTENDED AS A MITIGATION OF RISK ¿UNDER FLUOROSCOPY, USE THE BALLOON MARKER BANDS AND THE RADIOPAQUE STENT TO POSITION THE STENT CENTRALLY WITHIN THE LESION. DURING POSITIONING, VERIFY THAT THE STENT IS STILL CENTERED WITHIN THE BALLOON MARKER BANDS AND HAS NOT BEEN DISLODGED. AFTER STENT POSITIONING, HOLD THE DELIVERY SYSTEM IMMOBILE AND RETRACT THE CSI OR GUIDING CATHETER TO UNCOVER THE STENT. CAUTION: AFTER COMPLETELY RETRACTING THE CSI OR GUIDING CATHETER, DO NOT RE-ADVANCE IT OVER THE POSITIONED STENT TO AVOID DISLODGING THE STENT.¿ 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; TWO STENTS WERE PLACED SLIGHTLY TOO FAR DISTALLY AND FAILED TO COVER THE OSTIAL LESIONS. IN EACH CASE, A SECOND OVERLAPPING STENT WAS DEPLOYED MORE PROXIMALLY WITH SATISFACTORY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878223 UNKNOWN PALMAZ STENT CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CASHEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R