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 Pain (1994); Phlebitis (2004); Thrombus (2101)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician used the venaseal to successfully treat the right great saphenous vein(gsv), as per ifu.It was reported the patient attended a scan 6 days post procedure.The patient presented with severe pain in the treated limb and was diagnosed with phlebitis.The ultrasound showed an ehit (endovenous heat induced thrombus) class 2.The patient was prescribed ibuprofen 600mg x3, daily and tramadol-50mg 1-2 tabs every 6 hours or when necessary.

Manufacturer Narrative

Additional information: approx 1.5cc of cyanoacrylate was used to treat a 31 cm length.The patient continues to do well.The physician added that the patients coat profile was positive for elevated factor viii levels and heterozygous mthfr genetics- both putting her at increased risk of dvt the device was not received for evaluation.Six sonographic images were received for evaluation of the saphenofemoral junction (sfj) and great saphenous vein (gsv).Images 1 and 2 (time stamp az 07/12/2018 09:45:31am) are cross sectional views showing a thrombosis formation extending from the gsv into the sfj.Image 2 is of the vessel anatomy under compression.Images 3 and 4 (time stamp az 07/12/2018 09:43:46am) are cross sectional views showing a thrombosis formation in the sfj.Image 4 is of the vessel anatomy under compression.Image 5 (time stamp az 07/12/2018 09:49:03am) is a longitudinal view showing a thrombosis formation extending from the gsv into the sfj.Image 6 (time stamp az 07/12/2018 09:53:14am) is a longitudinal view showing a thrombosis formation extending from the gsv into the sfj.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7717455
• MDR Text Key: 114933669
• Report Number: 9612164-2018-01849
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 50655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 03/05/2018
• 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: 71 YR
• Patient Weight: 65