BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 24963636 · Received April 23, 2026

    Report

    Report Number
    1282497-2026-00023
    Event Type
    Death
    Date Received
    April 23, 2026
    Date of Event
    March 1, 2026
    Report Date
    April 23, 2026
    Manufacturer
    COVIDIEN LLC
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE TITLE: A FATAL CASE OF ACUTE PULMONARY EMBOLISM AFTER CYANOACRYLATE CLOSURE FOR VARICOSE VEINS ANN VASC DIS 2026; 19: 25-00113 DOI: 10.3400/AVD.CR.25-00113 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    AN 81-YEAR-OLD FEMALE WITH BILATERAL SMALL SAPHENOUS VEIN VARICOSITIES (CEAP, C2S, EP, AS, PR) UNDERWENT CYANOACRYLATE CLOSURE (CAC) AND STAB AVULSION UNDER GENERAL ANESTHESIA. FOURTEEN DAYS LATER, SHE DEVELOPED SEVERE DYSPNEA AND WAS DIAGNOSED WITH PULMONARY EMBOLISM (PE) AND DEEP VEIN THROMBOSIS. DESPITE ANTICOAGULATION, CARDIOPULMONARY SUPPORT, AND CATHETERDIRECTED THROMBECTOMY, SHE DIED 24 DAYS AFTER ADMISSION. ADEQUATE HEPARIN DOSING WITH ACTIVATED PARTIAL THROMBOPLASTIN TIME MONITORING IS IMPORTANT. PROLONGED PROCEDURES UNDER GENERAL ANESTHESIA MAY INCREASE PE RISK. EARLY AMBULATION, COMPRESSION THERAPY, AND FOLLOW-UP ULTRASONOGRAPHY BEYOND 24 HOURS MAY HELP DETECT DELAYED THROMBUS FORMATION AND REDUCE LIFE-THREATENING COMPLICATIONS AFTER CAC AN 81-YEAR-OLD FEMALE WITH A MEDICAL HISTORY OF HYPERLIPIDEMIA, HYPERTENSION, AND TYPE 2 DIABETES MELLITUS PRESENTED WITH BILATERAL SUPERFICIAL VARICOSE VEINS ASSOCIATED WITH DULLNESS (CEAP CLASSIFICATION: C2S, EP, AS, PR, AND SSV FOR BOTH SIDES; FIG. 1). LOWER EXTREMITY VENOUS ULTRASONOGRAPHY DID NOT REVEAL THROMBUS IN THE SUPERFICIAL OR DEEP VEINS OF THE LOWER LEGS, INCLUDING THE SAPHENOPOP LITEAL JUNCTION (SPJ), BUT DID REVEAL VALVE INSUFFICIENCY IN THE BILATERAL SSVS. HER DAILY MEDICATIONS INCLUDED BEZAFIBRATE 400 MG, LANSOPRAZOLE 15 MG, AND URSODEOXYCHOLIC ACID 600 MG. SHE HAD A BODY MASS INDEX OF 20.8 KG/M2 AND NO HISTORY OF ALLERGIES OR MALIGNANCY. COMPRESSION STOCKING THERAPY WAS INITIALLY PERFORMED, BUT SHE DISCONTINUED USE ON 1 LEG DUE TO DIFFICULTY IN APPLICATION. ONE MONTH LATER, SHE UNDERWENT CAC USING VENASEAL CLOSURE SYSTEM (MEDTRONIC, MINNEAPOLIS, MN, USA) FOR BILATERAL SSVS, AS WELL AS STAB AVULSION FOR VARICOSE VEINS IN THE RIGHT LOWER CALF; THE PROCEDURE LASTED 75 MIN AT ANOTHER CLINIC. CAC FOR BILATERAL SSVS REQUIRED 40 MIN, AND STAB AVULSION REQUIRED 15 MIN. THE TREATMENT WAS PERFORMED UNDER GENERAL ANESTHESIA WITHOUT ENDOTRACHEAL INTUBATION AT THE PATIENT¿S REQUEST. CYANOACRYLATE GLUE WAS INJECTED 5 TIMES ALONG AN 18-CM SEGMENT OF THE RIGHT SSV AND 4 TIMES ALONG A 15-CM SEGMENT OF THE LEFT SSV VIA PROXIMAL CALF PUNCTURES, FOLLOWED BY STAB AVULSION FOR VARICOSE VEINS OF THE RIGHT LOWER CALF. ALL PROCEDURES WERE PERFORMED IN THE PRONE POSITION, AND ELASTIC BANDAGES WERE APPLIED POSTOPERATIVELY. SHE BEGAN AMBULATION ABOUT 10 MINUTES AFTER THE PROCEDURE AND WAS SUBSEQUENTLY DISCHARGED THE SAME DAY. ON THE DAY FOLLOWING THE PROCEDURE, LOWER EXTREMITY VENOUS ULTRASONOGRAPHY REVEALED NO EVIDENCE OF ENDOVENOUS GLUE-INDUCED THROMBOSIS (EGIT) IN THE SPJ, DVT, OR RECANALIZATION OF THE TREATED VEINS AT THE OUTPATIENT VISIT. SEVEN DAYS AFTER CAC, SHE BEGAN EXPERIENCING PALPITATIONS AND EXERTIONAL DYSPNEA AND VISITED THE CLINIC, BUT SPECIFIC TESTS WERE NOT PERFORMED. ON DAY 14 POST-PROCEDURE, SHE PRESENTED WITH SEVERE DYSPNEA AND WAS ADMITTED TO OUR HOSPITAL BY REFERRAL WITH A SUSPECTED DIAGNOSIS OF PE. ON ADMISSION, HER PULSE RATE WAS 84 BPM (REGULAR); BLOOD PRESSURE, 126/84 MMHG; AND OXYGEN SATURATION, 92% ON 5 L/MIN OXYGEN VIA FACE MASK. LABORATORY DATA SHOWED ELEVATED LEVELS OF D-DIMER (7.2 G/ML) AND B-TYPE NATRIURETIC PEPTIDE (217.7 PG/ML). COAGULATION STUDIES, INCLUDING ANTITHROMBIN III, PROTEIN C, PROTEIN S, PLASMINOGEN, FIBRINOGEN, ANTINUCLEAR ANTIBODY, AND ANTICARDIOLIPIN ANTIBODY, REVEALED NO ABNORMALITIES PREDISPOSING TO THROMBOSIS. ELECTROCARDIOGRAM SHOWED SINUS RHYTHM WITH T-WAVE INVERSION IN LEADS I, AVL, II, III, AVF, AND V1¿V6. TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED RIGHT VENTRICULAR DILATATION AND MODERATE TRICUSPID REGURGITATION WITH A PRESSURE GRADIENT OF 43.3 MMHG INDICATING PULMONARY HYPERTENSION. CONTRAST-ENHANCED COMPUTED TOMOGRAPHY DEMONSTRATED MASSIVE PULMONARY EMBOLI IN THE PULMONARY TRUNK AND BILATERAL PULMONARY ARTERIES, AS WELL AS THROMBI IN THE LEFT COMMON FEMORAL VEIN, LEFT POPLITEAL VEIN, AND BOTH SSVS (FIG. 2). LEG VEIN ULTRASONOGRAPHY DEMONSTRATED SUPERFICIAL VEIN THROMBI IN BOTH SSVS AND DEEP VEIN THROMBI IN THE LEFT COMMON FEMORAL VEIN AND POPLITEAL VEIN. UPON ADMISSION, A 5000-UNIT INTRAVENOUS BOLUS OF UNFRACTIONATED HEPARIN WAS ADMINISTERED, FOLLOWED BY CONTINUOUS INFUSION AT A RATE OF 12000 UNITS PER DAY. UNFORTUNATELY, ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) WAS NOT MEASURED FOR MONITORING. ON THE MORNING OF THE SECOND DAY OF HOSPITALIZATION, SHE DEVELOPED SUDDEN LOSS OF CONSCIOUSNESS AND CARDIOVASCULAR COLLAPSE. PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) AND INTRA-AORTIC BALLOON PUMPING WERE INITIATED, AND CATHETER-DIRECTED THROMBECTOMY WAS PERFORMED. HER HEMODYNAMIC STATUS WAS STABILIZED WITHOUT ADMINISTRATION OF CATECHOLAMINES 5 DAYS AFTER PCPS INTRODUCTION. ON DAY 7 POST-PCPS INTRODUCTION, TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED MILD TRICUSPID REGURGITATION WITH A PRESSURE GRADIENT OF 33.8 MMHG, INDICATING IMPROVEMENT OF RIGHT VENTRICULAR FUNCTION AND PULMONARY HYPERTENSION. ON DAY 8 POST-PCPS INTRODUCTION, PCPS FLOW WAS REDUCED TO LESS THAN 1.0 L/MIN. SHE WAS SUCCESSFULLY WEANED FROM MECHANICAL SUPPORT 12 DAYS AFTER PCPS INTRODUCTION. HOWEVER, HER BLOOD PRESSURE TENDED TO DROP DUE TO SEPTIC SHOCK FROM DAY 17 POST-PCPS INTRODUCTION. SHE DIED 22 DAYS AFTER PCPS INTRODUCTION DUE TO ACUTE RESPIRATORY DISTRESS SYNDROME, PNEUMONIA, AND SEPSIS WITHOUT REGAINING CONSCIOUSNESS. AUTOPSY WAS NOT PERFORMED BECAUSE CONSENT COULD NOT BE OBTAINED FROM HER FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024996 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ COVIDIEN LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Death