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

Catalog Number SP-101

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932)

Event Date 07/26/2018

Event Type  Injury  

Manufacturer Narrative

No components from the venaseal closure system kit was received for evaluation.No sonographic images were received for evaluation.Four photographic images were received.The images are of the patient¿s treated leg and its response to treatment with prednisolone over time which showed a marked improvement in the patient¿s condition.One of the images is of a lab report that indicates the patient¿s white blood cell count as 7.4 x 10^9/l and eosinophils count as 1.25^9/l.The eosinophils count is raised above the reference range of 0.04 to 0.40.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient had treatment of great saphenous vein (gsv) using venaseal on (b)(6) 2018.The ifu was followed <(>&<)> the procedure completed without issue.The catheter tip was reported to be 5cm caudal to saphenofemoral junction (sfj) prior to initial delivery of adhesive.Compression was applied during the procedure.1 week post procedure the patient developed an arthus reaction type 3 and inflammation was evident on the treated segment of the patient's leg.The patient also reported their leg was painful.The patient was advised to continue compression and was prescribed arcoxia and diclofenac cream la.Two weeks later the patient returned and ciprofloxacin was prescribed along with betamethasone cream for the inflammation.The patients leg was still reported be swollen and indurated, not painful and with minimal tenderness.The ecg was unremarkable and the echo was satisfactory.Blood showed mild inflammation ¿ eosinophils 10%, troponin ok and chest x-ray was clear.Due to the raised eosinophils level, the patient was also prescribed prednisolone for 5 days.The patient returned one week later.The hypersensitivity was reported to be reducing.The patient prescribed steroids for a further week.Following this, the patient returned again for follow-up.The patient¿s condition was reported to be much improved ¿ steroids were prescribed in tapering dose for a further week.

• 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: 7989322
• MDR Text Key: 124488142
• Report Number: 9612164-2018-02854
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: SP-101
• Device Lot Number: 48014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2018
• Date Device Manufactured: 07/10/2017
• 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: 50 YR