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

Catalog Number SP-101

Device Problem Biocompatibility (2886)

Patient Problems Foreign Body Reaction (1868); No Code Available (3191)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient received bilateral lower great saphenous vein (gsv) treated with venaseal due to ulcers present on patients left leg an edema on right leg.The same venaseal kit used for treatment.Treatment area was from the lower thigh to the sapheno-femoral junction (sfj) on the right leg, and the ankle to the sfj on the left leg.Perforator veins on the patient¿s left leg were also treated.The patient¿s left leg which was deemed to have been worse prior to treatment, was fully healed one-month post procedure.The patient¿s right leg is reported to have developed oozing of serous fluid from the access site one-month post procedure.The access site is reported to have discharged polymerised glue.Currently, the access site is reported to be discharging sinus.The patient as prescribed antibiotics.The patient is currently visiting the doctor regularly for follow-up appointments.

Manufacturer Narrative

Image review five photographic images were received for evaluation.All of the images are of the patient¿s right leg in the area of the knee.The first image is of the patient¿s inner right leg in the area of the knee.On the right leg inner thigh, a sore has been circled with black marker.The sore exhibits some eschar along its edges.Just below the knee are two access sites that exhibit eschar.The second image is of the patient¿s inner right leg in the area of the knee.On the right leg inner thigh, a sore exhibit some eschar along its edges and a pinkish fluid appears to be at the center of the sore.Just below the knee are two access sites that exhibit eschar.The access site just below the knee has a pinkish fluid oozing from it.The third image is of the patient¿s inner right leg in the area of the knee.Just below the knee is an access sites that exhibit eschar and has a pinkish fluid oozing from it.The lower access site appears to be healed over.The fourth and fifth images are of the patient¿s inner right leg in the area of the knee.On the right leg inner thigh, a sore exhibit some eschar along its edges and a pinkish fluid appears to be at the center of the sore.Just below the knee are two access sites.The access site just below the knee has a pinkish fluid oozing from it.The lower access site appears to be healed.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: 9816548
• MDR Text Key: 189309037
• Report Number: 9612164-2020-01106
• 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: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: SP-101
• Device Lot Number: 54146
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention