BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PALMAZ STENT

    MDR report key: 8014083 · Received October 29, 2018

    Report

    Report Number
    9616099-2018-02470
    Event Type
    Death
    Date Received
    October 29, 2018
    Date of Event
    July 1, 1998
    Report Date
    October 29, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    FGE
    Adverse Event
    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 OF THESE PATIENTS DIED 6 MONTHS AFTER STENT INSERTION FROM A MASSIVE RETROPERITONEAL HEMORRHAGE REVEALED ON CT. AN AUTOPSY WAS NOT PERFORMED, BUT IN THE ABSENCE OF AN ABDOMINAL AORTIC ANEURYSM, IT WAS CONSIDERED LIKELY THAT STENT PLACEMENT LED TO A DELAYED VASCULAR CATASTROPHE SUCH AS PSEUDOANEURYSM RUPTURE." 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 ¿RETROPERITONEAL HEMORRHAGE¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS OR ONGOING DISEASE PROCESS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. AS AN AUTOPSY WAS NOT PERFORMED THE CAUSE OF THIS EVENT COULD NOT BE CONFIRMED AND THE STATEMENT APPORTIONING BLAME TO THE DEVICE IS MERE SUPPOSITION. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿POTENTIAL COMPLICATIONS ASSOCIATED WITH THE PERIPHERAL ARTERY STENT IMPLANTATION MAY INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: ARTERY INJURY, INCLUDING PERFORATION AND DISSECTION, PSEUDOANEURYSM FORMATION, RUPTURE OF RETROPERITONEUM OR NEIGHBORING ORGAN¿. NEITHER THE EVENT DESCRIPTION NOR THE VERY LIMITED 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 OF THESE PATIENTS DIED 6 MONTHS AFTER STENT INSERTION FROM A MASSIVE RETROPERITONEAL HEMORRHAGE REVEALED ON CT. AN AUTOPSY WAS NOT PERFORMED, BUT IN THE ABSENCE OF AN ABDOMINAL AORTIC ANEURYSM, IT WAS CONSIDERED LIKELY THAT STENT PLACEMENT LED TO A DELAYED VASCULAR CATASTROPHE SUCH AS PSEUDOANEURYSM RUPTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853472 UNKNOWN PALMAZ STENT CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CASHEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death