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 Skin Irritation (2076); Patient Problem/Medical Problem (2688)

Event Date 06/11/2019

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 a venaseal closure system to treat the distal leg great saphenous vein(gsv) on (b)(6) 2019.There were no issues reported during the procedure itself.It was reported that on (b)(6) 2019, irritation began along the treated vein segment and by (b)(6) blisters have started to form.The patient was prescribed keflex and steroids.

Manufacturer Narrative

The patient¿s lower right gsv (sfj to above knee where previous rf ablation was performed) was treated.Compression was not used.The patient reported a red, hot swollen leg.The patient was requested to mark the edges.Patient took benadryl and used ice.Patient returned for follow-up 3 days post procedure.The vein was reported to be closed.The erythema had spread from the original marked area.The skin was reported to be warm and very painful.Patient was prescribed nsaid¿s.Patient was prescribed a medrol dose pack for blister formation and improvement was seen in 24 hours.The patient returned 12 days later with worsening erythema and pain.The patient was prescribed another medrol dose pack.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the issue has resolved.The patient is no longer experiencing symptoms after the medrol dose pack.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: 8707440
• MDR Text Key: 148285980
• Report Number: 9612164-2019-02397
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 52797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2019
• Date Device Manufactured: 09/13/2018
• 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: 75 YR
• Patient Weight: 59