BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT PER 29MM 4-9MM MEDIUM

    MDR report key: 11928352 · Received June 3, 2021

    Report

    Report Number
    9616099-2021-04594
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    April 12, 1999
    Report Date
    June 3, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    UDI-DI
    20705032057285
    PMA / PMN Number
    K911581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 P294 STENT WAS PLACED IN AN UPPER EXTREMITY VEIN AT ANOTHER INSTITUTION AND AFTER REFERRAL, IT WAS FOUND THAT THE STENT MIGRATED TO THE RIGHT PULMONARY ARTERY (RPA) DUE TO IT BEING PRESUMED TO BE TOO SMALL. THE STENT WAS REPOSITIONED IN THE LEFT EXTERNAL ILIAC VEIN (L EIV) 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 MIGRATION¿ 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 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 POWERFLEX PLUS. IT IS NOT KNOWN IF THE RECOMMENDED BALLOON WAS USED IN THIS CASE. THE 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 P294 STENT WAS PLACED IN AN UPPER EXTREMITY VEIN AT ANOTHER INSTITUTION AND AFTER REFERRAL, IT WAS FOUND THAT THE STENT MIGRATED TO THE RIGHT PULMONARY ARTERY (RPA) DUE TO IT BEING PRESUMED TO BE TOO SMALL. THE STENT WAS REPOSITIONED IN THE LEFT EXTERNAL ILIAC VEIN (L EIV) 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
    823046 STENT PER 29MM 4-9MM MEDIUM CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CORPORATION P294 UNK 20705032057285

    Patients

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