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 Abscess (1690); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

Event date is approximate (reported that issue noted approximately 1 week prior to (b)(6) follow up).If information is provided in the future, a supplemental report will be issued.

Event Description

The physician used venaseal to successfully treat a 19cm segment of the left short saphenous vein (ssv).A separate procedure was previously performed on the right ssv.The ifu was followed and the procedure was completed normally and no additional treatment was required.The patient did not have any pain during the procedure.The patient had a dvt check on (b)(6) 2019 which was negative.It was reported that the patient experienced a skin irritation or burn one week prior to the (b)(6) visit.On (b)(6) the patient presented with two red hardened areas which had abscessed on the left leg and one on the right leg.The abscess was drained and hardened over.

Manufacturer Narrative

This patient had 4 venaseal procedures over two weeks in (b)(6) 2019.This reaction, as associated with both legs have been reported per procedure.A 51cm segment of the patient¿s right great saphenous vein (gsv) was treated and compression was applied.The tip of the venaseal was 5cm caudal to the sfj, the procedure was completed normally, and no additional treatment was required.A mild reaction was noted on one week post the dvt check.A steroid dose pak was prescribed.This was noted to be resolved 9 days post prescription of the steroid dose pak.The patient returned for follow-up visit one-month post resolution of mild reaction with the abscess.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: one image was received from the customer.Per the image, there is evidence of redness and abscessed at the treated site.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: 8598726
• MDR Text Key: 144662159
• Report Number: 9612164-2019-01650
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2019

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 Catalogue Number: VS-402
• Device Lot Number: 53285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 05/16/2019; 07/02/2019
• Supplement Dates FDA Received: 05/24/2019; 07/09/2019
• 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): Required Intervention
• Patient Age: 80 YR