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

Catalog Number SP-101

Device Problem Biocompatibility (2886)

Patient Problems Bruise/Contusion (1754); Foreign Body Reaction (1868); Inflammation (1932); Skin Discoloration (2074)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician intended to use a venaseal closure system to treat the short saphenous vein.The lumen was not flushed prior to use.The ifu was followed during preparation, procedure, post-procedure.A guidewire used for the insertion of the catheter.The procedure was carried out via external retro-malleolar access, guided echo, a 7f sheath and traditional technique of 5 cm higher without therapy, proximal double aliquot were used, 37 cm of axis were treated.Tumescent infiltration was not utilized.Hand compression was used.A week post procedure the patient started to develop ecchymosis.Approximately 10 months post procedure ultrasound shows an occluded axis and the patient mentioned an episode inflammation 3 months prior, it was reported as self-limited.Approximately 2 months later there was a new inflammatory reactivation of neighborhood access site which was treated with prednisone and chlorprimeton.Approximately 3 and a half months later, the patient presented with focal collection on site retro malleolar access with formal drainage and daily cures always with purulent material in volume of about 0.2 - 0.3 ml per day.5 days later there was no bacterial development but there was output of hard material, yellow / reddish coloration, whose sum of about 3 - 4 mmin total.No additional treatment was required.The event did not lead to or extend patient hospitalization.The patient suffered temporary injury.

Manufacturer Narrative

Additional information: wound care is being carried out at the access site.No additional treatment other than what was previously reported was given to date.The wound has completely healed from the wound care treatment.The culture test came back negative.A routine control of the issue will be done in one month.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: a single photograph was returned for evaluation.Photo is of a ruler and four pieces of excised yellow or reddish coloration hard material excised, 17 months post procedure, from retro malleolar access site.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

Update received regarding the control follow up visit indicated that the patient is in good shape, no wounds, negative culture test.No control will be performed for the next two months.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: 10201113
• MDR Text Key: 198701468
• Report Number: 9612164-2020-02333
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/13/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 06/25/2020; 07/15/2020; 08/12/2020
• Supplement Dates FDA Received: 07/13/2020; 07/17/2020; 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR