BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VYPRO MESH UNKNOWN PRODUCT

    MDR report key: 9927484 · Received April 6, 2020

    Report

    Report Number
    2210968-2020-02647
    Event Type
    Injury
    Date Received
    April 6, 2020
    Report Date
    March 17, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K002672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL ADVERSE EVENTS WILL BE SUBMITTED VIA MW# 2210968-2020-02646, MW# 2210968-2020-02648, AND MW# 2210968-2020-02649. 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: HERNIA (2018) 22:1083¿1088. DOI: HTTPS://DOI.ORG/10.1007/S10029-018-1815-Z. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 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 INVOLVED? WHAT ARE THE UNDERLYING CAUSES OF THE DEATH OF THE PATIENTS IN THE OPEN REPAIR GROUP? ARE THE CAUSES OF DEATH ATTRIBUTED WITH THE USE OF THE ETHICON PRODUCTS? (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: A COMPARISON OF LAPAROSCOPIC AND OPEN REPAIR OF SUBXIPHOID INCISIONAL HERNIAS. THE AUTHORS REVIEWED THEIR MANAGEMENT AND DATA OF THE SURGICAL REPAIR OF SUBXIPHOIDAL INCISIONAL HERNIAS WITH A SPECIAL FOCUS ON THE LONG-TERM SUCCESS OF THE TREATMENT. TWENTY EIGHT PATIENTS HAD UNDERGONE SURGICAL REPAIR OF A SUBXIPHOID HERNIA BETWEEN JANUARY 2010 AND JUNE 2015. TWENTY OF THESE PATIENTS (14 MALE AND 6 FEMALE; MEAN AGE: 58.8 ± 12.2 YEARS; MEAN BMI: 27.5 ± 4.8 KG/M2) WERE TREATED WITH AN OPEN APPROACH AND A RETROMUSCULAR MESH REPAIR (OPEN REPAIR GROUP) AND 8 PATIENTS (7 MALE AND 1 FEMALE; MEAN AGE: 60.1 ± 9.8 YEARS; MEAN BMI: 28.4 ± 4.8 KG/M2) RECEIVED A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) REPAIR (LAPAROSCOPIC REPAIR GROUP). DURING THE OPEN REPAIR, AFTER ACHIEVING AN ADEQUATE HERNIA OVERLAP OF AT LEAST 5 CM AROUND ALL EDGES, THE PERITONEUM AND THE POSTERIOR RECTUS SHEATH WERE CLOSED WITH A RUNNING SUTURE (PDS, ETHICON AND A LIGHTWEIGHT MESH WAS CUT TO SIZE. A ULTRAPRO MESH (ETHICON; USA) WAS USED IN 14 PATIENTS, A VYPRO MESH (ETHICON; USA) IN 4 CASES AND IN TWO PATIENTS AN OPTILENE MESH WAS USED. MESH FIXATION WAS PERFORMED ALONG ALL EDGES WITH INTERRUPTED SUTURES (VICRYL, ETHICON). THE ANTERIOR RECTUS SHEATH WAS ALSO CLOSED WITH A RUNNING SUTURE (PDS, ETHICON). REPORTED COMPLICATIONS IN THE OPEN REPAIR GROUP INCLUDED PROLONGED WOUND DRAIN DUE TO HIGH AMOUNTS OF FLUID SECRETION (N-1) WHICH REQUIRED A THERAPY BY LEAVING THE DRAINAGE FOR 7 DAYS, AND BLEEDING FROM THE MUSCLE WITH AN INSUFFICIENCY OF THE CLOSURE OF THE ANTERIOR FASCIA DIAGNOSED BY ULTRASOUND (N-1) IN WHICH THE PATIENT HAD A REOPERATION. LAPAROSCOPIC AND OPEN REPAIR OF SUBXIPHOID INCISIONAL HERNIAS ARE BOTH TECHNICALLY CHALLENGING COMPARED TO OTHER MIDLINE HERNIAS. REFERRING TO OUR RESULTS LAPAROSCOPIC REPAIR HAS SHORTER OPERATIVE TIMES, LOWER POSTOPERATIVE MORBIDITY WITH A HIGHER RECURRENCE RATE COMPARED TO OPEN REPAIR BUT THE SAMPLE SIZE IS TOO SMALL FOR AN OVERALL CONCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391687 VYPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention