BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18815826 · Received March 1, 2024

    Report

    Report Number
    2210968-2024-02173
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    May 9, 2022
    Report Date
    March 1, 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
    TX, 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, (2023); 76 (4): 987-996. HTTPS://DOI.ORG/10.1016/J.JVS.2022.05.012.

    Description of Event or Problem · 0

    TITLE: EARLY EXPERIENCE WITH VENOUS ARTERIALIZATION FOR LIMB SALVAGE IN NO-OPTION PATIENTS WITH CHRONIC LIMB-THREATENING ISCHEMIA. THE AIM OF THIS PROSPECTIVE COHORT REVIEW WAS TO REVIEW THE OUTCOMES OF VA AT OUR INSTITUTION. BETWEEN OCTOBER 2017 AND OCTOBER 2020, A TOTAL OF 41 PATIENTS (26 MALE, 15 FEMALE WITH MEAN AGE OF 63 [57.5-73.5]) WITH NO OPTION CLTI HAD UNDERGONE SUCCESSFUL OPEN HYBRID SUPERFICIAL OR DEEP ENDOVASCULAR VA; 21 (51.2%) HAD UNDERGONE A PURELY ENDOVASCULAR PROCEDURE AND 20 (48.8%), HYBRID VA. THE DATA WERE COLLECTED PROSPECTIVELY AT 1-MONTH, 6- MONTH, AND 1-YEAR INTERVALS FOR EACH PATIENT INCLUDED IN THE STUDY, WITH THE LAST DATA COLLECTED IN MAY 2021. TWO EXPERIENCED SURGEONS HAD PERFORMED ALL THE CASES INCLUDED IN THE PRESENT STUDY. THE OUTCOMES OF INTEREST INCLUDED PATENCY, WOUND HEALING, MALE, MAJOR AMPUTATION OF THE INDEX LIMB, AND DEATH. IN THE OPEN SURGERY TECHNIQUE, THEY USED 6-0 PROLENE SUTURE IN CONSTRUCTING ANASTOMOSIS. THE MEAN FOLLOW-UP PERIOD WAS 208 (73-396) DAYS. THE FOLLOWING EVENTS CANNOT BE RULED OUT AS COMPLAINTS: PATIENT INFORMATION (OPEN VA/ENDOVASCULAR VA): (N=12) HAD REQUIRED ASSISTANCE IN WOUND HEALING WITH A SPLIT THICKNESS SKIN GRAFT IN 19 PATIENTS WITH COMPLETE WOUND HEALING AT 12 MONTHS FOR PATIENTS WHO HAD UNDERGONE REINTERVENTION. (N=7) MAJOR ADVERSE LIMB EVENTS (POSTOPERATIVE ABOVE-THE-ANKLE AMPUTATION OR THE NEED FOR MAJOR REINTERVENTION INCLUDING NEW BYPASS, JUMP OR INTERPOSITION GRAFTING, THROMBECTOMY, OR THROMBOLYSIS). IN CONCLUSION, VA USING AN OPEN OR ENDOVASCULAR APPROACH IS EFFICACIOUS FOR LIMB SALVAGE FOR PATIENTS WITH NO-OPTION CLTI BUT REQUIRES A MULTIDISCIPLINARY APPROACH WITH HIGHLY TRAINED PROCEDURALISTS AND COMPETENT PERSONNEL FOR PRE- AND POST PROCEDURE SUPPORT TO ACHIEVE OPTIMAL OUTCOMES. OPEN SUPERFICIAL AND ENDOVASCULAR DEEP VA CAN RENDER COMPARABLE RESULTS WHEN A SPECIFIC SELECTION PROCESS IS UNDERTAKEN PREOPERATIVELY. THE LIMB SALVAGE RATES WERE ACCEPTABLE, AND THE WOUND HEALING RATES WERE SATISFACTORY FOR PATIENTS OTHERWISE DESTINED FOR MAJOR AMPUTATION, ALBEIT, WITH FAIRLY HIGH REINTERVENTION RATES. FURTHER ADOPTION OF VA IS WARRANTED TO PROMOTE LARGER STUDIES AND DEMONSTRATE THE GENERALIZABILITY OF THE SUCCESS IN THIS PATIENT POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290095 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention