BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9973448 · Received April 17, 2020

    Report

    Report Number
    2210968-2020-03176
    Event Type
    Injury
    Date Received
    April 17, 2020
    Report Date
    March 24, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 4/17/2020. CORRECTED H6 DEVICE CODE: 2993.

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) 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 (VICRYL SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS CITATION: INDIAN J GASTROENTEROL (NOVEMBER 2018) 37(SUPPL 1):A1¿A137. DOI: HTTPS://DOI.ORG/10.1007/S12664-018-0911-4. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: DIEULAFOY¿S LESION IN A PATIENT WITH CO-EXISTING ALD, DIABETES AND HEMOPHILIA A ¿ AN UNUSUAL CASE WITH UNEXPECTED CHALLENGES". AUTHORS: AASHISH RATHORE, ARVIND SAHNI, JAI DEV WIG, RITU PANKAJ, MEENAKSHI MALHOTRA, RAHATDEEP SINGH BRAR, SHALEEN RANA, APRA KALRA, ARUN SHARMA. CITATION: INDIAN J GASTROENTEROL (NOVEMBER 2018) 37(SUPPL 1):A1¿A137. DOI: HTTPS://DOI.ORG/10.1007/S12664-018-0911-4. DIEULAFOY'S LESION IS A LARGE CALIBER SUBMUCOSAL ARTERY WHICH ACCOUNTS FOR 1.5% OF ALL UPPER GI BLEEDS. A BLEEDING DIEULAFOY'S EVADES ENDOSCOPIC DIAGNOSIS IN APPROXIMATELY 1/3RD OF THE CASES AND CARRIES A MORTALITY OF 9% TO 13%. A PATIENT WAS PRESENTED WITH MASSIVE UGI BLEED AND HEMORRHAGIC SHOCK. ENDOSCOPY REVEALED A SMALL NON-BLEEDING ESOPHAGEAL VARICES, WITH STOMACH FULL OF BLOOD. THE PATIENT UNDERWENT LAPAROTOMY, GASTRIC DEVASCULARIZATION WAS DONE ALONG WITH REMOVAL OF BLOOD CLOT. AN ATERIAL SPURTER BELOW THE GE JUNCTION WAS UNDERRUN WITH VICRYL SUTURE (ETHICON). THE PATIENT DEVELOPED TWO INTRA-ABDOMINAL COLLECTIONS, AND FUNGIEMIA, SEPTICEMIA AND SHOCK WHICH WERE APPROPRIATELY MANAGED. THE PATIENT FINALLY WAS DISCHARGED AFTER 73 DAYS OF HOSPITALIZATION. A RARE AND CHALLENGING CASE OF DIEULAFOY'S LESION WITH HEMOPHILIA A AND CO-EXISTING ALD WITH DIABETES IS PRESENTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437069 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention