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

Catalog Number VS-402

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

Patient Problems Pulmonary Embolism (1498); Thrombosis (2100); Injury (2348)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal occluding device to treat the left great saphenous vein (gsv) successfully, and two days post procedure, patient had a normal follow up.Five days post follow up, patient had another venaseal procedure with the treatment of the right short saphenous vein (ssv).Two days later, follow up ultrasound was normal with the exception of and ehit class 1 at the left sfj.Patient days later was admitted with bilateral deep vein thrombosis (dvt) and a saddle pulmonary embolus.It is reported that ehit developed into deep vein thrombosis in patient.Patient is in hospital on heparin drug.

Manufacturer Narrative

Patient was discharged with oral anticoagulation.Patient is reported to be doing well.Patient will remain on oral anticoagulation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient¿s right leg was treated.The catheter tip was 6cm caudal to the sfj prior to delivery of adhesive.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: 9082140
• MDR Text Key: 158992611
• Report Number: 9612164-2019-03970
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2019
• 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: 68 YR
• Patient Weight: 146