BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT PER 20MM 4-9MM MED

    MDR report key: 11954496 · Received June 8, 2021

    Report

    Report Number
    9616099-2021-04613
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    April 12, 1999
    Report Date
    June 8, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    UDI-DI
    20705032057261
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: 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. SPECIFIC PRODUCT DETAILS ARE NOT AVAILABLE. THE EXACT EVENT DATE IS UNKNOWN. COMPLAINT CONCLUSION: 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 P204 STENT WAS INTENDED TO BE PLACED IN THE LEFT SUBCLAVIAN ARTERY (L SCA) BUT MIGRATED TO THE AORTA DUE TO IT GETTING CAUGHT ON AN UNKNOWN CATHETER. THE STENT WAS REPOSITIONED IN THE LEFT COMMON ILIAC ARTERY (L CIA) 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 ¿STENT INACCURATE PLACEMENT¿ 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.¿ 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.

    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 P204 STENT WAS INTENDED TO BE PLACED IN THE LEFT SUBCLAVIAN ARTERY (L SCA) BUT MIGRATED TO THE AORTA DUE TO IT GETTING CAUGHT ON AN UNKNOWN CATHETER. THE STENT WAS REPOSITIONED IN THE LEFT COMMON ILIAC ARTERY (L CIA) 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
    859071 STENT PER 20MM 4-9MM MED CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CORPORATION P204 UNK 20705032057261

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R UNKNOWN 3-5MM BALLOON CATHETER| UNKNOWN CATHETER