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

Model Number VS-402

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Phlebitis (2004); Rash (2033); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician used a venaseal closure system to treat segments of the great saphenous vein (gsv) on (b)(6) 2019.The procedure was completed on the day without any issue and the ifu was followed during preparation, procedure and post procedure.A guidewire was used for the insertion of the catheter.Two days post procedure (b)(6) 2019, patient experienced phlebitis over the area of the vein treated with venaseal.Post procedure on (b)(6) 2019 a rash covering the patient¿s body (over stomach and back area).On (b)(6) 2019, the rash extended to upper and lower extremities except the face.Hives were noted on upper and lower extremities.Patient was prescribed medications (benadryl, motrin, pepcid and prednisone) on (b)(6) 2019.

Manufacturer Narrative

Additional information: patient reports still having some discomfort around incision sites.Discoloration, redness and heat along the treated vein also reported.One incision is reported to have reopened and was bleeding for a handful of days, followed by a more pale-yellow drainage.This is reported to be improving but is ongoing.The second incision site has also reopened with a glue-like drainage initially but now minimal if any drainage.No bleeding reported.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient symptoms resisted a short course treatment of prednisone 50mg daily for 3 days and a prednisone dose pack, but rash finally subsidized after a high-dose steroid taper.As of last follow up visit, no residual signs of phlebitis or rash were noted.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Sonogram review: no components from the venaseal closure system kit were received for evaluation.No photographic images of the patient¿s symptoms were received for evaluation.A disc of dicom sonographic images was received for evaluation.Two folders of sonographic images were on the disc.The first folder is from an office visit that includes 69 pre-procedure sonograms.The second folder includes 25.2-days post-procedure sonograms.The second folder images show that the treated vein was successfully closed.Neither folder includes images of patient¿s reported symptoms.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: approximately 9 months post implant ((b)(6) 2020), the lower access site, venaseal was explanted with a total explanted vein length of about 4 inches.The wound culture showed high white blood cells (wbc) and no bacteria growth.The infection started above the lower incision (there was a discoloration ½ inch above since the procedure) and there was a piece of the glue close to the skin that caused a break in the skin.The abscess formed above the site.The explanted gsv segment was also found to have an infection without hypersensitivity.The second incision site is having a reaction.At this point, it has not reopened and it is being monitored to see if it will calm with allergy medication.No further patient injury 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.

Manufacturer Narrative

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: 8835578
• MDR Text Key: 152470979
• Report Number: 9612164-2019-03080
• 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,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 52449
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 68