BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT PER 30MM 4.0MM LARGE

    MDR report key: 11991631 · Received June 14, 2021

    Report

    Report Number
    9616099-2021-04634
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    April 12, 1999
    Report Date
    June 14, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    UDI-DI
    20705032057292
    PMA / PMN Number
    K911581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 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), 851¿859. HTTPS://DOI.ORG/10.1016/S1051-0443(99)70127-2, A PALMAZ P308 STENT WAS INTENDED TO BE PLACED IN THE LEFT COMMON ILIAC VEIN (L CIV) BUT MIGRATED TO THE INFERIOR VENA CAVA (IVC) DUE TO RUPTURE OF AN UNKNOWN BALLOON. THE STENT WAS REMOVED PERCUTANEOUSLY WITH ANOTHER UNKNOWN 3-5MM BALLOON CATHETER. 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¿ AND ¿BALLOON-SDS BURST - IN PATIENT¿ 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 STENT FOR THE ILIAC ARTERIES IS 316L STAINLESS STEEL, SLOTTED TUBE. THE STENT SHOULD BE CRIMPED OVER THE RECOMMENDED BALLOON DELIVERY CATHETER. MEASURE THE DIAMETER OF THE LESION TO DETERMINE THE APPROPRIATE SIZE STENT AND DELIVERY SYSTEM.¿ THE RECOMMENDED BALLOON WAS THE MAXI DS. 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.

    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), 851¿859. HTTPS://DOI.ORG/10.1016/S1051-0443(99)70127-2, A PALMAZ P308 STENT WAS INTENDED TO BE PLACED IN THE LEFT COMMON ILIAC VEIN (L CIV) BUT MIGRATED TO THE INFERIOR VENA CAVA (IVC) DUE TO RUPTURE OF AN UNKNOWN BALLOON. THE STENT WAS REMOVED PERCUTANEOUSLY WITH ANOTHER UNKNOWN 3-5MM BALLOON CATHETER. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888412 STENT PER 30MM 4.0MM LARGE CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CORPORATION P308 UNK 20705032057292

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR UNKNOWN 3-5MM BALLOON CATHETER| UNKNOWN BALLOON CATHETER