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

Model Number VS-402

Device Problem Biocompatibility (2886)

Patient Problems Rash (2033); Reaction (2414)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient had their great saphenous vein (gsv) and short saphenous vein (ssv) treated with venaseal.It is reported the patient had redness along the length of the gsv and had a diffused rash on her hand.The patient also reported having some itching over the weekend (approximately 2 days post procedure) and took some benadryl for 3 days.The patient called the physician¿s office 5 days post procedure to report the symptoms.It is reported the patient¿s rash continued to get worse and the patient attended the emergency room 9 days post procedure.The patient further developed difficulty breathing /wheezing.An epipen was administered and the patient was prescribed 40mg of prednisone daily in addition to zyrtec and hydroxyzine.The patient is due to visit an allergist and will then attend a vascular surgeon consultation to discuss vein stripping.

Manufacturer Narrative

Additional information: patient had venaseal treatment of the right great saphenous vein (gsv) and short saphenous vein (ssv).Six days later, the patient had venaseal treatment of the left gsv.The patient also reported having some itching in the bilateral lower extremity(ble) the next day after the last procedure, which continued to increase in severity.It was noted that the patient's condition had improved so the patient stopped taking benadryl.The patient¿s rash continued to get worse since the patient stopped taking the benadryl.The patient developed a rash on the inner knees and thighs with intense itching in bilateral feet, hands, and lower back.After a discussion with the medtronic representative and a review of venaseal study literature, the physician placed the patient on a medrol dose pack and instructed the restart of benadryl.A covid-19 test was ordered and the physician okayed the use of a 1% hydrocortisone cream the patient had at home.The patient was scheduled for a in person clinic appoint the next day.Ultrasound of ble showed the successful closure of bilateral gsv and right ssv.Despite the starting of the medrol pack, itching intensified overnight and showed throughout the patient's entire body.The patient also developed a diffuse urticarial rash over bilateral lower and upper extremities as well as the trunk.An allergist curbside consult recommended the use of oral prednisone (20 mg bid) and zyrtec (10 mg bid) and to discontinue the use of the medrol pack.A referral to an allergist was also placed.The patient attended the emergency room 9 days post procedure with pruritis and urticarial rash extending to into the scalp.Two days after, the patient went to the emergency room, in the early start of the day, with wheezing and continued worsening of rash and itching despite the medication changes.The patient was given iv steroid and later discharged home.The clinic contacted (b)(6) for an evaluation of the allergic reaction.Vein stripping is planned within the week after the patient's recent emergency room visit.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.

Manufacturer Narrative

Additional information: the patient started to have relief from the prednisone and did not move forward with the vein stripping.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.

Manufacturer Narrative

Image review: four photographic images were returned for review.The first photographic image were of the patient¿s left and right upper and forea rm area.The image shows erythema (redness) on both arms.The second image shows the patient torso and erythema is visible.The third photographic image shows a closer view of the erythema on the patient skin.The fourth image is also a closer view of the erythema on the patient¿s left upper arm.The returned photographs are consistent with the reported event.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.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: 10070022
• MDR Text Key: 195019161
• Report Number: 9612164-2020-01909
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2021
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 57968
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention