MAUDE Adverse Event Report: MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tachycardia (2095); Thromboembolism (2654)

Event Date 10/10/2021

Event Type  Injury  

Event Description

A journal article was submitted detailing a case report of a patient who underwent venaseal procedure for the treatment of varicose veins.7 days post procedure the patient felt chest pain and had slight shortness of breath while walking.The patient returned to the outpatient clinic for follow-up.The appearance of the bil.Lower limb was normal.In this case, both lower extremity veins underwent ultrasound examination, no thrombus was found in the deep venous system, and the great saphenous vein was closed at a distance of 5 cm from the junction of the common femoral vein.Electrocardiography revealed sinus tachycardia and a right ventricular strain pattern.For further confirm the diagnosis, the patient underwent chest computed tomography angiography.The results of the study showed that pulmonary thromboembolism occurred in the bilateral pulmonary arteries, and the severity of the right side was much greater than that of the left side.Patient was admitted to icu and systemic urokinase thrombolysis was administered.Enoxaparin for 7 days and rivaroxaban for 3 months were prescribed subsequently for anticoagulation.After 7 days of treatment, the patient¿s symptoms improved significantly, and the pulmonary embolism was also significantly improved by computer tomography angiography.The patient was transferred to the general ward and was discharged in a stable condition.Three months later, the pulmonary embolism under computerized angiography completely disappeared.The patient stopped taking anticoagulant drugs and followed up for 6 months without recurrence.

Manufacturer Narrative

Title: a rare case of pulmonary thromboembolism without deep vein thrombosis after nonthermal nontumescent ablative methods for varicose vein surgery author: chih-chien yen journal: annals of vascular surgery year: 2021 vol/issue: 79 ref: doi.Org/10.1016/j.Avsg.2021.07.036.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13660488
• MDR Text Key: 290558566
• Report Number: 9612164-2022-00873
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female