BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 15122447 · Received July 28, 2022

    Report

    Report Number
    9612164-2022-02871
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Report Date
    September 21, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS VENOUS DUPLEX ULTRASOUND IMAGE AT THE GROIN SHOWING MIXED ECHOGENIC THROMBUS (WITHIN MARKERS) EXTENDING INTO THE COMMON FEMORAL 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.

    Description of Event or Problem · 0

    PATIENT PRESENTED TO THE VASCULAR CLINIC WITH EXTENSIVE LOWER LIMB VENOUS INCOMPETENCY, ASSOCIATED VARICOSITIES AND TWO PRIOR EPISODES OF SUPERFICIAL THROMBOPHLEBITIS (STP) TREATED WITH ANTICOAGULATION BY HIS PRIMARY CARE PHYSICIAN. HE WAS OTHERWISE FIT AND WELL, WITH A MEDICAL HISTORY SIGNIFICANT FOR CONTROLLED HYPERTENSION. THERE WAS NO HISTORY OF SMOKING, MALIGNANCY, DEEP VEIN THROMBOSIS, THROMBOPHILIA OR OTHER PROTHROMBOTIC CONDITIONS. EXAMINATION REVEALED MULTIPLE VARICOSITIES IN THE BILATERAL MEDIAL THIGHS WITH PALPABLE OLD SUPERFICIAL PHLEBOLITHS, AND RETICULAR VEINS AT THE ANKLES WITH ASSOCIATED OEDEMA. PULSES WERE PRESENT THROUGHOUT THE LOWER LIMBS. ON INITIAL PRESENTATION, THE VENOUS CLINICAL SEVERITY SCORE WAS 13. DUPLEX ULTRASOUND OF THE LEFT LOWER LIMB INDICATED A MARKEDLY INCOMPETENT LONG SAPHENOUS VEIN (LSV) AND SFJ, PRIMARILY RESPONSIBLE FOR THE LOWER LEG VARICOSITIES. IN ADDITION, A SHORT SEGMENT OF STP WAS IDENTIFIED IN AN LSV MEDIAL THIGH TRIBUTARY, BUT NO DEEP VEIN THROMBOSIS. THIS WAS TREATED WITH THERAPEUTIC LOW MOLE CULAR WEIGHT HEPARIN AND COMPRESSION. ONCE THE STP HAD RESOLVED, ENDOVENOUS GLUE ABLATION WITH THE VCS WAS CARRIED OUT. FOLLOWING PROTOCOL, ACCESS WAS GAINED INTO THE LSV AT THE MID-CALF WITH ULTRASOUND GUIDANCE. THE VCS CATHETER TIP WAS PLACED IN THE LSV, 5 CM DISTAL TO THE SFJ, AND VCS ADHESIVE WAS DELIVERED WITH SIMULTANEOUS COMPRESSION NEAR THE SFJ. THE ENTIRE LENGTH OF THE LSV WAS TREATED WITH ADHESIVE AND SIMULTANEOUS COMPRESSION, UP TO THE POINT OF ACCESS AT THE MID-CALF. LOCAL ANESTHESIA WAS USED. TRANSDUCER WAS USED FOR COMPRESSION. A SEGMENT OF THE GREAT SAPHENOUS VEIN (GSV) WAS TREATED. THE LUMEN WAS FLUSHED PRIOR TO USE. IFU WAS FOLLOWED. A GUIDEWIRE WAS USED FOR THE INSERTION OF THE CATHETER. THE PATIENT RETURNED 1 MONTH LATER FOR REVIEW. APART FROM MILD TENDERNESS ON THE MEDIAL THIGH LASTING 48 HOURS AFTER THE PROCEDURE, HE REPORTED SIGNIFICANT IMPROVEMENT IN SYMPTOMS. THE SITE OF INCISION FOR LSV ACCESS HAD HEALED, AND THERE WAS MARKED IMPROVEMENT IN VENOUS OEDEMA WITH NO SUPERFICIAL THROMBOSIS PALPABLE. THE LSV AND ASSOCIATED VARICOSITIES HAD RESOLVED ON EXAMINATION, AND THE FOLLOW-UP VENOUS CLINICAL SEVERITY SCORE WAS 3, A SIGNIFICANT IMPROVEMENT. POSTOPERATIVE VENOUS DUPLEX CONFIRMED SUCCESSFUL ABLATION OF THE LSV FROM CALF TO GROIN, BUT THE SCAN ADDITIONALLY SHOWED A TONGUE OF PARTIALLY OCCLUSIVE MATERIAL EXTENDING INTO THE COMMON FEMORAL VEIN WITHOUT ACUTE DEEP VENOUS THROMBOSIS. THIS WAS MANAGED WITH SURVEILLANCE DUPLEX AND SERIAL CLINICAL OBSERVATION AT 1, 3, 6 AND 9 MONTHS, WITH SPONTANEOUS RESOLUTION BY 12-MONTH FOLLOW-UP. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2456939 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male