BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP ENDO

    MDR report key: 6792485 · Received August 14, 2017

    Report

    Report Number
    1527736-2017-00019
    Event Type
    Injury
    Date Received
    August 14, 2017
    Report Date
    July 27, 2017
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 08/14/2017. BATCH # UNK. AS A LOT/BATCH WAS NOT PROVIDED, A DEVICE HISTORY COULD NOT BE PERFORMED. EVENT DATE: EXACT DATE IS UNKNOWN. 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 THE PATIENT¿S ISSUES EXPERIENCED WERE RELATED TO AN ETHICON DEVICE DEFICIENCY AND IF SO, WHAT PRODUCTS SPECIFICALLY?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: A NOVEL SECURE TRANSFIXING BLOOD VESSEL OCCLUDER: COMPARISON WITH THE HEMOCLIP IN THE PORCINE MODEL. CITATION: JOURNAL OF SURGICAL RESEARCH 2017 MARCH; 209:211-219; HTTP://DX.DOI.ORG/10.1016/J.JSS.2016.09.056 THE PURPOSE OF THIS STUDY WAS TO COMPARE IN VIVO THE USE OF THE AMSEL VESSEL OCCLUDER (AVO) WITH THE LIGACLIP IN THE PORCINE MODEL FOR THE OCCLUSION OF BOTH ARTERIES AND VEINS RANGING IN EXTERNAL DIAMETER FROM 2MM TO 7MM. VESSEL CLOSURE OF ARTERIES AND VEINS WAS PERFORMED ON 10 SWINE TO COMPARE THE EASE OF USE, SAFETY, AND EFFICACY OF THE AVO WITH THE LIGACLIP AS WELL AS THE TISSUE RESPONSE AT 7 AND 30 DAYS. ON ONE OCCASION FOLLOWING DIVISION OF THE VESSEL BETWEEN THE TWO OCCLUDING LIGACLIPS, ONE OF THE CLIPS WAS OBSERVED TO SLIP FROM THE SITE OF OCCLUSION TO THE EDGE OF THE DIVIDED VESSEL. A SECOND LIGACLIP WAS IMMEDIATELY DEPLOYED MORE PROXIMALLY ON THE VESSEL TO PREVENT DISLODGMENT AND BLEEDING. IN THE POSTOPERATIVE FOLLOW-UP PERIOD, ONE OF THE PIGS, WHERE COMPLETE OCCLUSION WAS OBSERVED IMMEDIATELY AFTER IMPLANTATION AND DIVISION OF THE VESSEL, SUFFERED A MASSIVE HEMORRHAGE FROM A GROIN VESSEL (PROXIMAL FEMORAL VEIN) OCCLUSION SITE APPROXIMATELY 16 HOURS AFTER SURGERY AND EXSANGUINATED. POSTMORTEM EXAMINATION REVEALED THAT THE LIGACLIP FROM THE PROXIMAL OCCLUDED SEGMENT OF THE DIVIDED FEMORAL VEIN HAD DISLODGED, CAUSING A MASSIVE HEMATOMA AND HEMORRHAGE. FOR THE STUDIES OF ¿HOLDING¿ PRESSURES AND RESISTANCE TO MECHANICAL DISLODGMENT, THE LIGACLIPS COULD ALL BE EASILY DISLODGED AND REMOVED FROM ALL TESTED VESSELS WITH RATHER WEAK TUGS WITH THE FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573426 LIGACLIP ENDO CLIP, IMPLANTABLE FZP ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1