BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT PER 15MM MEDIUM

    MDR report key: 11928390 · Received June 3, 2021

    Report

    Report Number
    9616099-2021-04595
    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
    20705032057247
    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 P154 STENT WAS INTENDED TO BE PLACED IN THE AXILLARY VEIN BUT MIGRATED TO THE RIGHT VENTRICLE DUE TO IT BEING TOO SMALL. PERCUTANEOUS RETRIEVAL WAS UNSUCCESSFUL DUE TO THE PATIENT DEVELOPING CHEST PAIN WHEN TRACTION WAS PLACED ON A SNARE PASSED AROUND THE STENT. THE STENT HAD TO BE SURGICALLY REMOVED FROM THE HEART AND AT SURGERY, THE STENT WAS FOUND TO BE ENTANGLED IN THE TRICUSPID VALVE. THE PATIENT DEVELOPED TRICUSPID REGURGITATION AFTER ATTEMPTED STENT RETRIEVAL, WHICH MAY HAVE BEEN CAUSED BY MANIPULATION OF THE STENT. 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¿, ¿CHEST PAIN¿ AND ¿TRICUSPID REGURGITATION¿ 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 INDICATED FOR USE IN THE TREATMENT OF ATHEROSCLEROTIC DISEASE IN PERIPHERAL ARTERIES BELOW THE AORTIC ARCH AND FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE. MEASURE THE DIAMETER OF THE REFERENCE VESSEL TO DETERMINE THE APPROPRIATE SIZE STENT AND DELIVERY SYSTEM.¿ AS THE PRODUCT IS INDICATED FOR USE IN THE ARTERIES AND THIS PRODUCT WAS USED IN THE VEIN IT IS CONSIDERED OFF LABEL USAGE AND A VIOLATION OF THE IFU. 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 P154 STENT WAS INTENDED TO BE PLACED IN THE AXILLARY VEIN BUT MIGRATED TO THE RIGHT VENTRICLE DUE TO IT BEING TOO SMALL. PERCUTANEOUS RETRIEVAL WAS UNSUCCESSFUL DUE TO THE PATIENT DEVELOPING CHEST PAIN WHEN TRACTION WAS PLACED ON A SNARE PASSED AROUND THE STENT. THE STENT HAD TO BE SURGICALLY REMOVED FROM THE HEART AND AT SURGERY, THE STENT WAS FOUND TO BE ENTANGLED IN THE TRICUSPID VALVE. THE PATIENT DEVELOPED TRICUSPID REGURGITATION AFTER ATTEMPTED STENT RETRIEVAL, WHICH MAY HAVE BEEN CAUSED BY MANIPULATION OF THE STENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824667 STENT PER 15MM MEDIUM CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CORPORATION P154 UNK 20705032057247

    Patients

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