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

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Reaction (2414); Skin Inflammation (2443)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

Age: average age.Sex: majority gender.Date of event: date of publication journal article title: persistent type iv hyper sensitivity after cyanoacrylate closure of the great saphenous vein journal of vascular surgery cases and innovative techniques volume 5 number 3.If information is provided in the future, a supplemental report will be issued.

Event Description

Abstract: the venaseal (medtronic, minneapolis, minn) cyanoacrylate closure system is a nonthermal technique for ablating saphenous veins using a proprietary n-butyl cyanoacrylate.One possible side effect is an allergic reaction to cyanoacrylate.We report the case of a (b)(6) year old woman treated with cyanoacrylate closure who developed a persistent type iv hypersensitivity reaction.The patient elected to have the vein excised, and the histologic features were consistent with a type iv hypersensitivity reaction.Event description: the study reported a case of a (b)(6) year old woman treated with venaseal in the great saphenous vein.The patient has a history of allergy to sulpha and penicillin.The patient was treated 5cm caudal to the sfj to the proximal calf, 1.3ml of adhesive used.Additionally, 3ml of 1% sodium tetradecyl sulphate was injected into the branch veins in multiple injections, remote from the gsv.The patient presented post procedure with persistent ache, tiredness and swelling in the left leg.The patient presented post procedure complaining of leg pain and redness, thought to be either phlebitis or an allergic reaction and was treated with oral benadryl and topical cream.Further follow-up was carried out the patient complained of progressive leg pain, chills and erythema over the medical thigh, due to concerns about infection the patient was treated with keflex for 5days with improvement reported.On further follow-up the patient presented with persistent leg pain , erythema and swelling, and prescribed medrol dose pack and referred to an allergist.The patient elected to have the vein endoscopically excised, after excision the patient had symptoms of pain and selling in the treated limb becoming reduced over a two-year period.Conclusion: type iv hypersensitivity reactions to ca are a potential complication of treatment.The treating provider should be aware of this potential complication when selecting patients for this therapy.

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: 8975368
• MDR Text Key: 156940448
• Report Number: 9612164-2019-03809
• 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
• Report Date: 09/16/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 09/16/2019
• 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: 49 YR