BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7639567 · Received June 26, 2018

    Report

    Report Number
    2210968-2018-73851
    Event Type
    Injury
    Date Received
    June 26, 2018
    Report Date
    June 6, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: WORLD NEUROSURGERY. 2016; 93: 215 220. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CAROTID ENDARTERECTOMY ON ANTIPLATELET AGENTS IN THE ERA OF POINT-OF-CARE TESTING AUTHOR: KARAM MOON, MICHAEL NANASZKO, MICHAEL R. LEVITT, BRADLEY A. GROSS, JOSEPH M. ZABRAMSKI, ROBERT F. SPETZLER, PETER NAKAJI WEB ADDRESS:HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.05.080 CITATION: WORLD NEUROSURGERY. 2016; 93: 215 220. THE AUTHORS SOUGHT TO DETERMINE WHETHER USING POINT-OF-CARE ASSESSMENT OF PLATELET INHIBITION REVEALS RISK FACTORS FOR OPERATIVE COMPLICATIONS OR PREDICTS CLINICAL OUTCOMES. A TOTAL OF 79 PATIENTS (50 MALE AND 29 FEMALE) WITH 86 LESIONS WHO MET THE INCLUSION CRITERIA FOR THIS STUDY, WITH A MEAN AGE OF 70.9 ± 10.0 YEARS (AGE RANGE: 40 TO 100 YEARS OLD) UNDERWENT CAROTID ENDARTERECTOMY AND WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, THE ARTERIAL CLOSURE AND REPAIR IS CARRIED OUT WITH A PROLENE RUNNING 6-0 SUTURE. THE DECISION TO USE PATCH GRAFTS IS LEFT TO THE DISCRETION OF THE PRIMARY NEUROSURGEON; THEY WERE NOT USED COMMONLY IN THESE PATIENTS. REPORTED COMPLICATIONS INCLUDED TOTAL NECK HEMATOMA (N-15) WHICH REQUIRED RE-OPERATION FOR HEMATOMA EVACUATION AND HEMOSTASIS (N-3) AND SURGICAL NECK HEMATOMA (N-3). IT WAS CONCLUDED THAT CLOPIDOGREL USE WITHIN 5 DAYS OF CAROTID ENDARTERECTOMY INDEPENDENTLY PREDICTED POST-OPERATIVE NECK HEMATOMAS, MOST OF WHICH WERE MANAGED CONSERVATIVELY. INDIVIDUAL BIOLOGICAL RESPONSES TO ASPIRIN AND CLOPIDOGREL REMAIN HIGHLY VARIABLE AS MEASURED BY AVAILABLE TESTS, AND THE STRENGTH OF THE RESPONSE MAY HAVE CLINICAL IMPLICATIONS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479250 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention