BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH UNKNOWN PRODUCT

    MDR report key: 11724279 · Received April 26, 2021

    Report

    Report Number
    2210968-2021-03637
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    March 7, 2019
    Report Date
    March 31, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 06/28/2021. 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. 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. CITATION OF ARTICLE: HERNIA (2019) 23:347¿354. HTTPS://DOI.ORG/10.1007/S10029-019-01899-8. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCTS (VYPRO MESH, PROCEED MESH, ULTRAPRO MESH, PROLENE MESH) 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 INVOLVED?

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CLARIFY 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCTS (VYPRO MESH, PROCEED MESH, ULTRAPRO MESH, PROLENE MESH) 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 INVOLVED? EVENTS RELATED TO PROLENE MESH CAPTURED VIA 2210968-2021-03636, EVENTS RELATED TO ULTRAPRO MESH CAPTURED VIA THIS REPORT, EVENTS RELATED TO PROCEED MESH CAPTURED VIA 2210968-2021-03638, EVENTS RELATED TO VYPRO MESH CAPTURED VIA 2210968-2021-03639.

    Description of Event or Problem · 1

    TITLE: PRE-OPERATIVE CT SCAN MEASUREMENTS FOR PREDICTING COMPLICATIONS IN PATIENTS UNDERGOING COMPLEX VENTRAL HERNIA REPAIR USING THE COMPONENT SEPARATION TECHNIQUE. THE AIM OF THIS STUDY IS TO EXPLORE THE USE OF CT SCAN-DERIVED BODY MORPHOMETRICS [VISCERAL FAT VOLUME (VFV), SUBCUTANEOUS FAT VOLUME (SFV), TOTAL FAT VOLUME (TFV) AND LOSS OF DOMAIN (LOD)] TO PREDICT REHERNIATION AND SSI IN PATIENTS UNDERGOING COMPLEX VENTRAL HERNIA REPAIR USING THE CST. ADULT PATIENTS (18¿75 YEARS OF AGE AT TIME OF OPERATION) WHO UNDERWENT COMPLEX VENTRAL HERNIA REPAIR USING THE CST (WITH OR WITHOUT THE USE OF MESH REINFORCEMENT) BETWEEN 2000 AND 2013 AND WHO HAD A PREOPERATIVE CT SCAN WERE ELIGIBLE FOR INCLUSION. PATIENTS WERE EXCLUDED IF THE CT SCAN WAS PERFORMED EARLIER THAN 6 MONTHS PRIOR TO SURGERY TO MINIMIZE THE INFLUENCE OF CHANGES IN WEIGHT, OR IF THE SCAN DID NOT COVER THE FULL ABDOMEN. VYPRO MESH (ETHICON), PROCEED MES(ETHICON), ULTRAPRO MESH (ETHICON) AND PROLENE MESH (ETHICON) WERE UTILIZED IN THIS STUDY. A TOTAL OF 65 PATIENTS WERE INCLUDED AND HAD A CT SCAN PERFORMED WITHIN 6 MONTHS BEFORE SURGERY AND BOTH THE CT SCANS AND THE FOLLOW-UP WERE PERFORMED AT THE SAME HOSPITAL. MESH REINFORCEMENT WAS USED IN 45 PATIENTS (69.2%). MESH WAS PLACED IN A SUBLAY (73.1%), INTRAPERITONEAL (16.2%), ONLAY (7.6%) OR INLAY (1.5%) POSITION. CST WAS PERFORMED UNI- OR BILATERAL RELEASE OF THE EXTERNAL OBLIQUE APONEUROSIS IS PERFORMED TO ACHIEVE MEDIAL TRANSLATION OF THE RECTUS COMPLEX, WITH OR WITHOUT MOBILIZATION OF THE POSTERIOR RECTUS SHEATH FOR ADDITIONAL MEDIALIZATION. THE AIM IS ALWAYS TO CLOSE THE POSTERIOR FASCIA AND ALSO SPARE THE PERI-UMBILICAL PERFORATORS IF POSSIBLE. A SYNTHETIC MESH WAS USED ONLY IF THERE WAS NO CONCURRENT INFECTION DURING RECONSTRUCTION OF THE ABDOMINAL WALL. IF A MESH WAS USED IT WAS PLACED WITH AN OVERLAP OF 5 CM ON EACH SIDE OF THE DEFECT. IN SOME PATIENTS WITH A NON-CONTAMINATED WOUND, RECONSTRUCTION WITHOUT MESH REINFORCEMENT WAS USED BECAUSE OF A CONCURRENT TRIAL THAT WAS BEING PERFORMED AT THE TIME. REPORTED COMPLICATIONS INCLUDED REHERNIATION (N=18) AND SURGICAL SITE INFECTION (N=14). IN CONCLUSION VISCERAL FAT VOLUME, SUBCUTANEOUS FAT VOLUME AND HERNIA SAC VOLUME DERIVED FROM CT SCAN MEASUREMENTS MAY BE USED TO PREDICT REHERNIATION AND SSI IN PATIENTS UNDERGOING COMPLEX VENTRAL HERNIA REPAIR USING CST. THESE FINDINGS MAY AID IN OPTIMIZING PATIENT-TAILORED PREOPERATIVE RISK ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624255 ULTRAPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1