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 Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient¿s short saphenous vein (ssv) was treated with venaseal.Ifu was followed.Post procedure it reported the patient experienced dvt post-op 3cm from the spj.

Manufacturer Narrative

Additional information: patients right great saphenous vein (gsv) was also treated.Patient¿s ssv measured 7mm.The catheter tip was 5cm caudal to the saph endo-femoral junction (sfj) prior to delivery of adhesive.Compression was used.Vein closure was achieved.Post procedure it is reported no dvt was evident, buy there was thrombus at the proximal end of the glue, 3.3 cm away from saphenopopliteal junction and ssv.No medical treatment.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: thrombus was diagnosed 1-day post procedure.The condition has been resolved without medical intervention.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review a disc of dicom images were received for evaluation.The disc contained four still images from the treatment procedure and 61 still images from a follow-up office visit.No evidence of deep vein thrombosis was found in any of the images.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: 8748613
• MDR Text Key: 149653134
• Report Number: 9612164-2019-02612
• 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,Followup
• Report Date: 10/30/2019

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
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 52599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 07/05/2019; 07/05/2019; 10/29/2019
• Supplement Dates FDA Received: 07/09/2019; 07/30/2019; 10/30/2019
• Date Device Manufactured: 08/30/2018
• 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): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 64