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

Catalog Number SP-101

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

Patient Problems Pulmonary Embolism (1498); Atrial Fibrillation (1729); Injury (2348); Thromboembolism (2654)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a venaseal occluding device to treat 14 segments in the great saphenous vein (gsv) ((b)(6) 2019).The procedure was reported to be successful.It was reported that 72 hours post procedure, patient developed thrombus pulmonary embolism, was hospitalized and treated with enoxaparin 1mg/kg and was referred.

Manufacturer Narrative

Correction: date mfr rec reported as 12-sep-2019 originally.Corrected to 03-sep-2019.Additional information: bilateral venaseal treatment was carried out.Ifu was followed.For the treatment of perforating veins in proximity with malleolar ulcer, polidocanol foam (3%, 10 c) was injected under duplex guidance after completing the venaseal procedure.Two days post procedure an ultrasound showed complete occlusion of the saphenous veins with no extension to the deep venous system.Adhesive was observed in the proximal saphenous vein with a margin of less than 1 centimeter.Four days post-venaseal procedure the patient presented with atrial fibrillation and was sent to the or.A trans thoracic echocardiography showed dilation of both atriums, and because of this finding a thoracic angio ct was done and showed pulmonary embolism of the segmental arteries for the upper right lobe.The duplex ultrasound showed echogenic material extending from the left saphenous vein to the posteromedial aspect of the common femoral vein.That material had acoustic shadow, suggesting cyanoacrylate on the deep venous system.The patient was discharged from the hospital and is doing fine.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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9114908
• MDR Text Key: 159922050
• Report Number: 9612164-2019-04068
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: SP-101
• Device Lot Number: 48528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2019
• Date Device Manufactured: 09/01/2017
• 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: 72 YR
• Patient Weight: 65