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

Catalog Number SP-101

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/10/2021

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 13cm of the right great saphenous vein (gsv) with 5 pushes and 25cm of the right short saphenous vein (ssv) with 9 pushes.The catheter was used to complete the therapy without problems.There was no adverse event or device malfunction.No history of deep vein thrombosis prior to the initial procedure.It was confirmed through post-operative ultrasound test dus that the therapeutic vein was occluded.The patient had a risk factor life style of standing for a long time.There was no treatment history of varicose veins in the lower limbs for both limbs, ceap classification was diagnosed at c2.There were no concomitant drugs at the time of the initial procedure.The patient visited the hospital for 7-10 days follow-up after the scheduled visit.No medication was taken after the procedure.There was no adverse event or device malfunction.The patient visited hospital for 1 month follow-up after the scheduled visit.It was confirmed that there was no patency with dus.There were no concomitant drugs.There was no adverse event or device malfunction.The patient visited the hospital for 3 months follow-up after the scheduled visit.With dus, patency of 22cm in the middle region of the abdomen and 5cm in the distal region of the knee region of the ssv was confirmed.It was confirmed that there was no other patency.Additional treatment for the treated blood vessel was not performed.The physician reported that there was no adverse event or device malfunction.The patient visited the hospital for 1 year follow-up after the scheduled visit.Asymptomatic deep vein thrombosis (dvt) was observed in dus.The physician reported that the event was not severe for dvt, and that cac was performed on the other side for asymptomatic flounder clots on the other contralateral side, and cac was performed on the right side of the left lower limb on a different day, so a causal relationship with the device was unknown and there was no causal relationship with the procedure.Treatment for the confirmed dvt was not performed.The patient was scheduled to visit the hospital again, but has not visited the hospital again, so the prognosis was unknown.With dus, a patency of 5 cm was observed in the distal region - the mid thigh region and 25 cm in the knee - the mid abdomen region of the ssv.Additional treatment for the treated blood vessel was not performed.Approximately 1 month post index procedure, venaseal was used and additional treatment scheduled prior to the initial procedure was performed.The additional treatment on (b)(6) 2020 was a procedure scheduled before the first procedure, and was a treatment on the opposite side (left lower limb).The site of onset of dvt was as shown in the yellow highlight above (asymptomatic flounder thrombus on the opposite side).A 25 cm patency was reported at 3-month follow-up, but no additional treatment has been given at this time.

Manufacturer Narrative

Additional information: no treatment was given for confirmed dvt.The patient is scheduled to visit the hospital but has not visited.Prognosis is unknown.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 implant date was updated.The left short saphenous vein (ssv) was treated during second procedure, a vessel originally planned for treatment.No adverse events occurred on the day of treatment.Dvt not verified on day of treatment.At one year follow up for both procedures performed, physician reported that the event was not severe for dvt, and that cac was performed for asymptomatic flounder clots on the left ssv, and cac was performed on a different day.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: re-examination was performed approximately 2 months post index procedure.No additional treatment and contralateral side soleus venous thrombosis (peripheral type dvt).The prognosis improved.The patient's problem has been resolved.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.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11981647
• MDR Text Key: 255613887
• Report Number: 9612164-2021-02263
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• 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
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 59