BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18754234 · Received February 21, 2024

    Report

    Report Number
    2210968-2024-01650
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    September 22, 2020
    Report Date
    February 21, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: JOURNAL OF VASCULAR SURGERY. HTTPS://DOI.ORG/10.1016/J.JVS.2020.09.031.

    Description of Event or Problem · 0

    TITLE: STAGED TOTAL ARCH REPLACEMENT, FOLLOWED BY FENESTRATED-BRANCHED ENDOVASCULAR AORTIC REPAIR, FOR PATIENTS WITH MEGA AORTIC SYNDROME. THE AIM OF THIS STUDY IS TO REVIEW THE CLINICAL OUTCOMES OF A STAGED APPROACH USING TOTAL ARCH REPLACEMENT (TAR) WITH AN ELEPHANT TRUNK OR A FROZEN ELEPHANT TRUNK, FOLLOWED BY FENESTRATED-BRANCHED ENDOVASCULAR AORTIC REPAIR (F-BEVAR) FOR PATIENTS WITH MEGA AORTIC SYNDROME. INCLUDED IN THIS STUDY ARE 11 CONSECUTIVE PATIENTS (8 MEN; MEAN AGE, 71 6 7 YEARS) TREATED BY STAGED TAR AND F-BEVAR FROM (B)(6) 2014 TO (B)(6) 2018. 11 PATIENTS HAD UNDERGONE CONVENTIONAL STAGED OPEN REPAIR. FIRST-STAGE PROCEDURES INCLUDED TAR WITH ET OR FROZEN ET (FET). THE DISTAL ANASTOMOSIS BETWEEN THE COLLAR AND STUMP OF THE AORTA WAS PERFORMED USING RUNNING 4-0 PROLENE SUTURE, REINFORCED BY CIRCUMFERENTIAL PLEDGETED 4-0 MATTRESS SUTURES. REPORTED COMPLICATION: POST DISSECTION ANEURYSM (N-6) DEGENERATIVE ANEURYSMS (N-5) CONCLUSIONS: A STAGED APPROACH TO TREATMENT OF MEGA AORTIC SYNDROME USING TAR AND F-BEVAR IS A FEASIBLE ALTERNATIVE FOR SELECTED HIGH-RISK PATIENTS. LARGER CLINICAL EXPERIENCE AND LONGER FOLLOW-UP ARE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575904 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention