BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 11700291 · Received April 21, 2021

    Report

    Report Number
    9612164-2021-01585
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    April 19, 2021
    Report Date
    June 14, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTION D6A: IMPLANT DATE: ADDITIONAL INFORMATION: THE PATIENT PRESENTED SWELLING OF LOWER LEGS AND PAIN. IT WAS REPORTED THAT THE EGIT AFTER THE TREATMENT OF THE GSV BECAME EGIT 4 AFTER PASSING THROUGH THE PERFORATOR VEIN INTO THE SOLEAL VEIN. THE EGIT THAT MAY HAVE OCCURRED IN THE SAPHENOUS FEMORAL JUNCTION (SFJ) WAS CLASS 1 AND IT DEVELOPED FROM THE PERFORATOR VEIN WITHOUT ANY FURTHER ISSUES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 3 DAYS AFTER THE PROCEDURE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    UPDATED SECTION D6A. IMPLANTED DATE. IMAGE REVIEW: A SINGLE WORD DOCUMENT CONSISTING OF A SINGLE PHOTOGRAPH OF A HANDWRITTEN PROCEDURE NOTE IN THE PHYSICIAN¿S NATIVE LANGUAGE WAS PROV IDED FOR REVIEW. THE PROCEDURE NOTE INCLUDES A DIAGRAM OF THE TREATED VEINS, WITH THE VENASEAL TREATED VESSELS IN RED. A PORTION OF RED EXTENDS INTO THE SAPHENOUS FEMORAL JUNCTION AND FROM A LOWER LIMB PERFORATOR VEIN. AN ARROW POINTS TO THE SAPHENOUS FEMORAL JUNCTION IN THE RIGHT LEG WITH THE INITIALS EGIT1. EGIT STANDS FOR ENDOVENOUS GLUE-INDUCED THROMBOSIS. THE 1 REFERS TO CLASS 1 WHICH IS DEFINED AS VENOUS THROMBOSIS TO SUPERFICIAL DEEP JUNCTION BUT NOT EXTENDING INTO THE DEEP SYSTEM. THE LOWER LIMB PERFORATOR VEIN IS CLASS 4. CLASS 4 IS DEFINED AS OCCLUSIVE DEEP VEIN THROMBOSIS OF THE SOLEAL VEIN. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN USED VENASEAL OCCLUDING DEVICE DURING PROCEDURE TO TREAT THE GREAT SAPHENOUS VEIN (GSV). THE CATHETER WAS FLUSHED PRIOR TO USE. IFU WAS FOLLOWED. A GUIDEWIRE WAS USED FOR THE INSERTION OF THE CATHETER. THE VEIN EFFECTIVELY CLOSED. IT WAS REPORTED THAT EGIT 4 HAD OCCURRED, AND THE PATIENT WAS HOSPITALIZED. WHETHER IT WAS THROMBUS OR GLUE WITH ANITHROMBOTIC DRUG TENDED TO DISAPPEAR, SO THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO FURTHER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597137 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND SP-101 61307

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention