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

Model Number SP-101

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

Patient Problem Inflammation (1932)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

After treatment with venaseal the patient developed a granuloma at the access site.It was reported that intervention was required during a follow up consultation to remove the granuloma.

Manufacturer Narrative

Additional information: the patients left gsv was treated.The granuloma is reported to be located at the midthigh of the left leg and not at the access site.There were no challenges related to the location of the catheter tip prior to delivery of adhesive.The patient presented with skin issues along with aches and pains during follow-up but with no systematic issues.The granuloma was identified on the (b)(6) 2018 and removed on the (b)(6).The patient reportedly has two other ¿lumps¿ more proximal to this one on the same leg.Further follow up with this patient is planned by the physician and any new information received by medtronic from these will be reported to the fda.Four images were received from the customer.Per the images, a foreign material/granuloma was removed from the patients thigh.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: patient has not received treatment yet for the two other 'lumps'.These are suspected to be related to the venaseal procedure as there was no growth on swab.Foreign body reaction consistent with extravasated glue on pathology.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: additional information received indicates following review of the patient, no further treatment is planned at this time.The other 'lumps' will be monitored.The histology results indicate an inflammatory reaction which is believed to be due to the venaseal tracking up a tributary.Image analysis: per additional analysis conducted by medical affairs on the review of the sonograms and images, a hypo echoic mass with irregular margins appeared to have extensions to the saphenous vein.Based on the images showing series of hyper echoic characteristics, it is difficult to tell the location of the saphenous vein in the image.The patient presented with skin issue and pain during follow-up.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: patient had history of ceap c4a chronic venous disease, previous venous avulsions at a different anatomical location, no history of allergy or hypersensitivity type reactions.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: 8159863
• MDR Text Key: 130197704
• Report Number: 9612164-2018-03608
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: SP-101
• Device Lot Number: 48979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2018
• Date Device Manufactured: 10/02/2017
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 85 KG