BEUDAMED
    FDA Adverse Event Death Summary report: N

    STENT PER 10MM MEDIUM

    MDR report key: 11966804 · Received June 9, 2021

    Report

    Report Number
    9616099-2021-04623
    Event Type
    Death
    Date Received
    June 9, 2021
    Date of Event
    April 12, 1999
    Report Date
    June 9, 2021
    Manufacturer
    CARDINAL HEALTH MEXICO
    Product Code
    FGE
    UDI-DI
    20705032057223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SLONIM, S. M., DAKE, M. D., RAZAVI, M. K., KEE, S. T., SAMUELS, S. L., RHEE, J. S., & SEMBA, C. P. (1999). MANAGEMENT OF MISPLACED OR MIGRATED ENDOVASCULAR STENTS. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY : JVIR, 10(7), 851859. HTTPS://DOI.ORG/10.1016/S1051-0443(99)70127-2. ACCORDING TO THE LITERATURE ARTICLE BY SLONIM, S. M., DAKE, M. D., RAZAVI, M. K., KEE, S. T., SAMUELS, S. L., RHEE, J. S., & SEMBA, C. P. (1999). MANAGEMENT OF MISPLACED OR MIGRATED ENDOVASCULAR STENTS. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY : JVIR, 10(7), 851859. HTTPS://DOI.ORG/10.1016/S1051-0443(99)70127-2, A PALMAZ P104 STENT WAS INTENDED TO BE PLACED IN THE RIGHT RENAL ARTERY (RRA) BUT MIGRATED TO THE AORTA DUE TO IT BEING TOO SMALL. THE STENT WAS REMOVED PERCUTANEOUSLY WITH AN UNKNOWN 3-5MM BALLOON CATHETER. THE PATIENT DIED SIX DAYS AFTER PERCUTANEOUS PROCEDURE DUE TO MULTIORGAN FAILURE FROM A SPONTANEOUS TYPE B AORTIC DISSECTION. 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 MIGRATION, MULTIORGAN FAILURE AND TYPE B AORTIC DISSECTION COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS ARE UNKNOWN. AS NO LOT NUMBER WAS SUPPLIED A PHR COULD NOT BE COMPLETED. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE THE PALMAZ BALLOON-EXPANDABLE PERIPHERAL STENT IS A 316L STAINLESS STEEL, SLOTTED TUBE. THE STENT SHOULD BE CRIMPED OVER THE RECOMMENDED BALLOON DELIVERY CATHETER. SEE MATERIALS REQUIRED TABLE FOR THE RECOMMENDED CORDIS MAXI" DS, AND POWERFLEX¿ PLUS INDIVIDUAL PRODUCT DESCRIPTIONS, AND RECOMMENDED ACCESSORY DEVICES. POTENTIAL COMPLICATIONS ASSOCIATED WITH PERIPHERAL ARTERY AND TRANSHEPATIC BILIARY STENT IMPLANTATION MAY INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: STENT MIGRATION/EMBOLIZATION. THE RECOMMENDED BALLOON WAS THE POWERFLEX PLUS. IT IS NOT KNOWN IF THE RECOMMENDED BALLOON WAS USED IN THIS CASE. THE LIMITED INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME. THE CODE 4581V WAS USED SINCE THE APPROPRIATE TERMS FOR MULTIORGAN FAILURE AND TYPE B AORTIC DISSECTION IN UNAVAILABLE.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE ARTICLE BY SLONIM, S. M., DAKE, M. D., RAZAVI, M. K., KEE, S. T., SAMUELS, S. L., RHEE, J. S., & SEMBA, C. P. (1999). MANAGEMENT OF MISPLACED OR MIGRATED ENDOVASCULAR STENTS. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY : JVIR, 10(7), 851859. HTTPS://DOI.ORG/10.1016/S1051-0443(99)70127-2, A PALMAZ P104 STENT WAS INTENDED TO BE PLACED IN THE RIGHT RENAL ARTERY (RRA) BUT MIGRATED TO THE AORTA DUE TO IT BEING TOO SMALL. THE STENT WAS REMOVED PERCUTANEOUSLY WITH AN UNKNOWN 3-5MM BALLOON CATHETER. THE PATIENT DIED SIX DAYS AFTER PERCUTANEOUS PROCEDURE DUE TO MULTIORGAN FAILURE FROM A SPONTANEOUS TYPE B AORTIC DISSECTION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862652 STENT PER 10MM MEDIUM CATHETER, BILIARY, DIAGNOSTIC FGE CARDINAL HEALTH MEXICO UNK 20705032057223

    Patients

    Seq Age Sex Outcome Treatment
    1 Death UNKNOWN 3-5MM BALLOON CATHETER.