BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PALMAZ BALLOON EXPANDABLE STENT

    MDR report key: 11716710 · Received April 23, 2021

    Report

    Report Number
    9616099-2021-04458
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    February 8, 1995
    Report Date
    April 23, 2021
    Manufacturer
    CARDINAL HEALTH MEXICO
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICE IS A PALMAZ STENT BUT THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. THE ARTICLE WAS PUBLISHED IN 195 AND NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. A COPY OF THE PUBLICATION IS ATTACHED TO THIS REPORT. THE CITATION IS AS FOLLOWS: NG, F. F., GRIFKA, R. G., NIHILL, M. R., & MULLINS, C. E. (1995). REPEAT DILATION OF INTRAVASCULAR STENTS IN CONGENITAL HEART DEFECTS. CIRCULATION, 92(4), 893¿897. AS REPORTED IN THE LITERATURE ARTICLE BY ING, F. F., GRIFKA, R. G., NIHILL, M. R., & MULLINS, C. E. (1995). REPEAT DILATION OF INTRAVASCULAR STENTS IN CONGENITAL HEART DEFECTS. CIRCULATION, 92(4), 893¿897.HTTPS://DOI.ORG/10.1161/01.CIR.92.4.893, AFTER PLACEMENT OF AN UNKNOWN PALMAZ STENT THE STENT WAS DISFIGURED. THE STENT WAS ¿PRUNED¿ AT THE TIME OF REDILATION. THERE WAS NO REPORTED PATIENT INJURY. 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 UNDEREXPANDED¿ 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, CATALOGUE CODE OR OTHER PRODUCT INFORMATION WAS SUPPLIED A PHR COULD NOT BE COMPLETED. DURING A BRANCH PULMONARY ARTERY STENOSIS STENTING PROCEDURE, IT IS STANDARD PRACTICE TO INITIALLY PLACE A STENT THAT CAN BE FURTHER EXPANDED DUE TO SOMATIC GROWTH OVER TIME, THEREFORE THEY ARE USUALLY PLACED AND DELIBERATELY UNDEREXPANDED TO TAKE INTO ACCOUNT THE YOUNG AGE OF THE RECIPIENT AND THUS A SMALLER TARGET VESSEL AND TO ALLOW FOR THE FURTHER EXPANSIONS EXPECTED. THE USE OF PALMAZ STENTS IN THE PEDIATRIC PULMONARY SYSTEM IS NOT INDICATED IN THE LABELING AND AS SUCH IS CONSIDERED OFF LABEL USAGE. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿TO ASSURE FULL EXPANSION, INFLATE TO AT LEAST THE NOMINAL PRESSURE RECOMMENDED ON THE CATHETER LABEL.¿ THE VERY 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

    AS REPORTED IN THE LITERATURE ARTICLE BY ING, F. F., GRIFKA, R. G., NIHILL, M. R., & MULLINS, C. E. (1995). REPEAT DILATION OF INTRAVASCULAR STENTS IN CONGENITAL HEART DEFECTS. CIRCULATION, 92(4), 893¿897. HTTPS://DOI.ORG/10.1161/01.CIR.92.4.893, AFTER PLACEMENT OF AN UNKNOWN PALMAZ STENT THE STENT WAS DISFIGURED. THE STENT WAS ¿PRUNED¿ AT THE TIME OF REDILATION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616297 UNKNOWN PALMAZ BALLOON EXPANDABLE STENT CATHETER, BILIARY, DIAGNOSTIC FGE CARDINAL HEALTH MEXICO N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1