BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PALMAZ BALLOON EXPANDABLE STENT

    MDR report key: 11738318 · Received April 28, 2021

    Report

    Report Number
    9616099-2021-04481
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    February 8, 1995
    Report Date
    April 28, 2021
    Manufacturer
    CARDINAL HEALTH MEXICO
    Product Code
    FGE
    PMA / PMN Number
    P890017
    Adverse Event
    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 1995 AND NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. THE CITATION IS AS FOLLOWS: 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), 893897. 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), 893897. HTTPS://DOI.ORG/10.1161/01.CIR.92.4.893, AFTER PLACEMENT OF AN UNKNOWN PALMAZ STENT, THE STENT DEVELOPED ADDITIONAL AREAS OF STENOSIS THAT WERE FOUND AT FOLLOW UP CATHETERIZATION. THIS WAS A RETROSPECTIVE REVIEW OF PEDIATRIC PATIENTS WITH CONGENITAL HEART DISEASE WHO UNDERWENT CARDIAC CATHETERIZATION AND STENT IMPLANTATION. THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. STENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF DISEASE. HOWEVER, THE USE OF THE PALMAZ STENT IS OFF LABEL USAGE AS THE DEVICE IS NOT INDICATED FOR PEDIATRIC USAGE. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE THE PALMAZ XL BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT IS INDICATED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE. TO ASSURE FULL EXPANSION, INFLATE TO AT LEAST THE NOMINAL PRESSURE RECOMMENDED ON THE CATHETER LABEL. 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

    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), 893897. HTTPS://DOI.ORG/10.1161/01.CIR.92.4.893, AFTER PLACEMENT OF AN UNKNOWN PALMAZ STENT, THE STENT DEVELOPED ADDITIONAL AREAS OF STENOSIS THAT WERE FOUND AT FOLLOW UP CATHETERIZATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636538 UNKNOWN PALMAZ BALLOON EXPANDABLE STENT CATHETER, BILIARY, DIAGNOSTIC FGE CARDINAL HEALTH MEXICO N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 0.038-IN SHORT-TIP SUPERSTIFF EXCHANGE WIRE (MEDIT