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

Catalog Number SP-101

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Phlebitis (2004); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal occluding device during procedure to treat the great saphenous vein (gsv.The lumen was flushed prior to use.Ifu was followed.A guide wire was used for the insertion of the catheter.It was reported that there was no problem during the procedure but patient suffered phlebitis 3 years post treatment.The phlebitis was in the gsv treated after 3 years.The patient was operated on due to venous reflux with venaseal 3 years ago.After several episodes of phlebitis in one treated leg, the affected saphenous segment was surgically removed no further patient injury reported.

Manufacturer Narrative

Additional information: the microbiology results were negative.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: 60 cm of the left gsv and 75 cm of the right gsv was treated.The patient noticed the reaction the first time approximately 2 years and 8 months after the procedure.The first time the patient noticed the reaction, the patient had come to the office for a hard, red, hot, and painful cord inner left thigh in the left inner saphenous area.Eco-duplex svp without alterations was conducted.3 cm of the internal saphenous was closed without reflux and the venaseal remained inside.The painful area was approximately 5-6 cm in length and increased echogenicity of the fat around the vein.The pain was compressed.The physician prescribed the heparin, antibiotics, and anti-inflammatories.Approximately two months later, the physician received an update that the episode had subsided after 10 days post treatment and the patient was fine until 3-4 days, where the same symptoms occurred.The physician repeated the treatment.Approximately 1 and 2 months later the same symptoms appeared.At the 2 months later mark, the patient presented a segment of similar characteristics in mid below the knee of about 3 cm.The physician asked for ac covid-19 and pcr and d-dimero tests, which al l came back negative.It was originally thought the microthrombus was caused by covid-19 and the physician prescribed antibodies, pcr, d dimer, and hypercoagulability study.Each episode was treated with heparin, antibiotics, and anti-inflammatories.The results came back normal.The patient had the affected vessel segment explanted approximately 7 months after.A microbiology test was conduct and currently awaiting results.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

Device evaluation five photographic images and a physician¿s report were received for analysis.One image is from the procedure that excised the vessel out of the patient¿s upper left thigh.Four of the images are from a pathological report of slides taken from the vessel excised from the patient.The physician¿s report was in spanish and describes the treatment the patient has received.The report indicates that samples exhibit chronic granulomatous inflammation of a foreign body type occupying the lumen of the vessel.Per the initial reported event description, the microbiology results were negative.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: 10690014
• MDR Text Key: 211672891
• Report Number: 9612164-2020-03973
• 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,Followup,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: SP-101
• Device Lot Number: 46231
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 92