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

Catalog Number SP-101

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Reaction (2414); Skin Inflammation (2443)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient received venaseal treatment of the right small saphenous vein (ssv) and the left great saphenous vein (gsv).The catheter was used to perform puncturing at ssv from the ankle and to perform puncturing at gsv from the knee, and the targeted treatment was completed without problems.During the initial procedure, bump resection of the left gsv was also performed in parallel.It was noted that there was no patency in both legs in postoperative dus.No deviation from ifu was reported during procedure.12cm of the patient¿s right ssv and 31cm of the patient¿s left gsv were treated.5 aliquots of adhesive were delivered to the patient¿s right ssv, and 12 to the left gsv with both vessels being treated with the same venaseal kit.The doctor prescribed loxoprofen prophylactically for one-week post treatment.The patient returned for a follow-up appointment 7 days post procedure and no adverse events were noted.The patient attended a hospital 20 days post procedure and complained of erythema, pruritus and pain on the interior part of the left thigh.The physician described the patient symptoms as non-severe and prescribed claritin (prescription medicine) and liniment topical cream steroid (rinderon vg).The physician reported that there was a causal relationship with the product because it was an allergic reaction caused by the adhesive, and that there was no causal relationship with the procedure.The patient returned for a follow-up appointment one-month post index procedure and it was reported that the patient had recovered.No further patient injury reported.

Manufacturer Narrative

Image review: the customer has provided a photo of the patients leg post procedure.The photo shows redness and possible swelling of the interior part of the left thigh medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 10377843
• MDR Text Key: 201998401
• Report Number: 9612164-2020-02904
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

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 Expiration Date: 07/31/2021
• Device Catalogue Number: SP-101
• Device Lot Number: 56194
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 84