BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PALMAZ STENT

    MDR report key: 11807617 · Received May 11, 2021

    Report

    Report Number
    9616099-2021-04533
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    February 15, 1995
    Report Date
    May 11, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE REPORT ALSO REPRESENTS NOTIFICATION OF 1 EVENT FOR HEMORRHAGE LEADING. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICES ARE PALMAZ STENTS BUT THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. THE CITATION IS AS FOLLOWS (PERCUTANEOUS USE OF STENTS TO CORRECT PULMONARY ARTERY STENOSIS IN YOUNG CHILDREN AFTER CAVOPULMONARY ANASTOMOSIS. AMERICAN HEART JOURNAL, 130(6), 12451249). A COPY OF THE PUBLICATION IS ATTACHED TO THIS REPORT. MOORE, J. W., SPICER, R. L., PERRY, J. C., MATHEWSON, J. W., KIRKPATRICK, S. E., GEORGE, L., UZARK, K., MAINWARING, R. L., & LAMBERTI, J. J. (1995). PERCUTANEOUS USE OF STENTS TO CORRECT PULMONARY ARTERY STENOSIS IN YOUNG CHILDREN AFTER CAVOPULMONARY ANASTOMOSIS. AMERICAN HEART JOURNAL, 130(6), 12451249. HTTPS://DOI.ORG/10.1016/0002-8703(95)90149-3, DURING PLACEMENT OF AN UNKNOWN PALMAZ STENT, THE PATIENT DEVELOPED ACUTE BLOOD LOSS AND REQUIRED BLOOD TRANSFUSION. A JUDKINS 5.2F RIGHT CORONARY GUIDE CATHETER WAS USED AS GUIDE FOR THE PROCEDURE. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS THE STERILE LOT NUMBERS WERE NOT PROVIDED. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS AND WITHOUT FILMS OF THE EVENT, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. PULMONARY HEMORRHAGE (OR PULMONARY HAEMORRHAGE) IS AN ACUTE BLEEDING FROM THE LUNG, FROM THE UPPER RESPIRATORY TRACT AND THE TRACHEA, AND THE ALVEOLI. WHEN EVIDENT CLINICALLY, THE CONDITION IS USUALLY MASSIVE. LOCALIZED PULMONARY BLEEDING USUALLY REQUIRES LOCAL TREATMENT, LIKE BRONCHOSCOPIC THERAPY, BRONCHIAL ARTERY EMBOLIZATION OR SURGERY. DIFFUSE ALVEOLAR HAEMORRHAGE MUST BE TREATED SYSTEMICALLY, I.E. BY IMMUNOSUPPRESSIVE THERAPY IN CASES OF VASCULITIS OR BY MEDICAL TREATMENT OF COAGULATION DISORDERS. HEMORRHAGE IS A WELL-KNOWN DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU AS SUCH. THE INSTRUCTION FOR USE CAUTIONS USERS TO AVOID OVEREXPANSION OF THE BALLOON TO PREVENT BLEEDING, DISSECTION OR PATIENT DISCOMFORT. THE USE OF PALMAZ STENTS IN THE PEDIATRIC PULMONARY SYSTEM IS NOT INDICATED IN THE LABELING AND AS SUCH IS CONSIDERED OFF LABEL USAGE. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    MOORE, J. W., SPICER, R. L., PERRY, J. C., MATHEWSON, J. W., KIRKPATRICK, S. E., GEORGE, L., UZARK, K., MAINWARING, R. L., & LAMBERTI, J. J. (1995). PERCUTANEOUS USE OF STENTS TO CORRECT PULMONARY ARTERY STENOSIS IN YOUNG CHILDREN AFTER CAVOPULMONARY ANASTOMOSIS. AMERICAN HEART JOURNAL, 130(6), 12451249. HTTPS://DOI.ORG/10.1016/0002-8703(95)90149-3, DURING PLACEMENT OF AN UNKNOWN PALMAZ STENT, THE PATIENT DEVELOPED ACUTE BLOOD LOSS AND REQUIRED BLOOD TRANSFUSION. A JUDKINS 5.2F RIGHT CORONARY GUIDE CATHETER WAS USED AS GUIDE FOR THE PROCEDURE. THE DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702356 UNKNOWN PALMAZ STENT CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CORPORATION PXXXXX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 0.038¿ UNKNOWN GUIDEWIRE| 11F COOK LONG SHEATH| 5.2F MEDITECH ANGIOPLASTY CATHETER| 5F UNKNOWN SHEATH| HEPARIN