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

Catalog Number SP-101

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It is reported out of 1365 patients and 2595 treated veins, 19 patients have had an lymph fistula (0.73%).In 19 cases, the fistula was opened and cleaned then they healed without complications in all described cases.Physician reported event as not a complication but just as a side effect which occurs with every surgery treatment in a ratio of 2-3 % and it is not deemed to be related to venaseal.

Manufacturer Narrative

A2: average patient age additional information: the study was conducted to evaluate the outcome of venaseal treatment over a period of 88 months.1335 patients and 2532 veins were treated.Area treated for the population, gsv (1713 cases), ssv (642 cases), vsal (92 cases), femoropopliteal vein (18 cases) and giacomini¿s vein (2 cases).For the treatment of one vein 1.2 ml to 1.8 ml of glue was administered.The majority of patients left without compression stockings following treatment.A 12 ¿ chamber compression therapy immediately post op was carried out in the case of 30% of patients.Bleeding for more than 12hrs ex punctio is reported in 22 cases.Of the 19 patients reported to have had an lymph fistula (0.73%), the fistula was opened, cleaned and sterile strip was applied.The physician has stopped delivering adhesive when the sheaths was out of the skin and has withdrawn the catheter jerky.Glue with cutaneous perforation was observed 10 ¿ 12 months after sealing in 3 cases.The area was surgically opened and sent to histopathological examination.The perforations healed after 14 days.Unspecific inflammatory reaction (not phlebitis) of tissue was reported in 190 veins.Duplex control follow-up over 88 months, 99.53% closure rate observed on first follow-up.Between 14-30 day follow-up, a 97.47% closure rate as observed with 50 partial and 14 completely recanalized veins reported.Three to four month follow-up reports 53 and 22 complete recanalization¿s, with overall closure rate reported as 97.07% for those able to follow-up (n=1941) follow-up carried out eight to ten months post procedure revealed 62 partial and 37 complete recanalization¿s, concluding a closure rate of 96.09% (n=1650).It is reported that no further recanalization¿s are reported with overall closure rate over 87 months equal to 96.09%.No further patient injury was reported.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: 9773860
• MDR Text Key: 181548363
• Report Number: 9612164-2020-00953
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SP-101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR