BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP

    MDR report key: 12102067 · Received July 1, 2021

    Report

    Report Number
    3005075853-2021-03682
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    November 15, 2019
    Report Date
    June 2, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014584
    PMA / PMN Number
    K141952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. 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 AUTHOR/ SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/ CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: EVALUATION OF A NOVEL POWERED VASCULAR STAPLER IN LAPAROSCOPIC NEPHRECTOMY. AUTHORS: VIRAJ A MASTER, STEVE LEUNG, TOBY PAGE, ANTHONY BLACKER, SIMON WILLIAMS, ANIRUDDHA CHAKRAVARTI, GRENVILLE OADES, GURMINDER MANN, CHANDRU SUNDARAM, ALBERTO BREDA, CARLOS HERNANDEZ, ERIN E CREEDON, MICHAEL L SCHWIERS, DAVID W SINGLETON, JASON R WAGGONER AND ELLIOTT J FEGELMAN. CITATIONS: GLOB SURG, 2019, DOI: 10.15761/GOS.1000211. THE PURPOSE OF THIS STUDY WAS TO DETERMINE IF USE OF A POWERED VASCULAR STAPLER (PVS) DURING LAPAROSCOPIC NEPHRECTOMY OR NEPHROURETERECTOMY PROCEDURES WOULD YIELD AN EQUIVALENT RATE OF ADDITIONAL HEMOSTATIC INTERVENTIONS TO STANDARD OF CARE (SOC) STAPLERS. A PROSPECTIVE, RANDOMIZED, MULTICENTRE, CONTROLLED STUDY WAS CONDUCTED COMPARING THE USE OF PVS TO SOC IN LAPAROSCOPIC NEPHRECTOMY OR NEPHROURETERECTOMY. A TOTAL OF 302 SUBJECTS WERE SCREENED FOR STUDY PARTICIPATION, AND 270 WERE RANDOMIZED TO UNDERGO LAPAROSCOPIC NEPHRECTOMY OR NEPHROURETERECTOMY USING EITHER SOC STAPLER (N = 139) OR PVS (N=131) FOR TRANSECTION OF RA AND RV. MEAN AGE OF THE SUBJECTS WAS 63.8 YEARS (RANGE 19 TO 94), AND A MAJORITY (87.4%) WERE WHITE. THE TEST DEVICE WAS THE ECHELON FLEX¿ POWERED VASCULAR STAPLER (PVS, ETHICON ENDO-SURGERY, INC., CINCINNATI OH) COMPARED TO THE STANDARD OF CARE STAPLER (SOC). EACH SUBJECT UNDERWENT A SIMPLE LAPAROSCOPIC OR RADICAL NEPHRECTOMY OR A LAPAROSCOPIC NEPHROURETERECTOMY IN COMPLIANCE WITH THE STANDARD PROCEDURE AT THE RESPECTIVE STUDY SITE. THE PRINCIPAL INVESTIGATOR AT EACH SITE PERFORMED THE TRANSECTION OF THE RA/RV WITH EITHER THE SOC STAPLER OR THE PVS WITH 35 MM VASCULAR WHITE RELOADS (ETHICON ENDO-SURGERY, INC., CINCINNATI, OH). SUBJECTS CONTINUED WITH THEIR CURRENT MEDICAL CARE WHILE IN THE STUDY, INCLUDING MEDICATIONS. ANTICOAGULANTS AND NSAIDS TAKEN PREOPERATIVELY UP TO 30 DAYS PRIOR TO THE PROCEDURE AND THE STOP DATES WERE RECORDED, AS WERE ANY MEDICATIONS PRESCRIBED DUE TO ADVERSE EVENTS (AES). THE PROTOCOL INCLUDED FOUR VISITS: SCREENING, SURGERY, POSTOPERATIVE THROUGH DISCHARGE, AND A POSTOPERATIVE VISIT/PHONE CALL (APPROXIMATELY 4 WEEKS AFTER SURGERY OR AS PER SOC). REPORTED COMPLICATIONS INCLUDED INTRAOPERATIVE HAEMOSTATIC INTERVENTIONS, POSTOPERATIVE BLEEDING THAT REQUIRED INTERVENTION, BLOOD LOSS, HAEMORRHAGE, HAEMATURIA, HEMATOMA AND CLAVIEN-DINDO GRADES I, II, III. IN CONCLUSION THE PVS PERFORMED SAFELY AND EFFECTIVELY IN NEPHRECTOMY AND EXHIBITED A RATE OF HAEMOSTATIC INTERVENTION THAT WAS NOT STATISTICALLY DIFFERENT THAN THE SOC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997565 ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PVE35A 10705036014584

    Patients

    Seq Age Sex Outcome Treatment
    1