MAUDE Adverse Event Report: INTACT VASCULAR, INC. TACK ENDOVASCULAR SYSTEM (6F, 4.0-8.0MM); SCAFFOLD, DISSECTION REPAIR

Model Number	206135061
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The tack endovascular system (tes) was used in a peripheral procedure in the distal common femoral artery.During use, a tack was deployed in the artery, removed the device, and performed angio.The physician wanted to place a second tack proximal to the original tack location; however, did not post dilate the first tack and pushed the tack further down the artery.The system was removed without deploying the second tack, and a balloon was used to post dilate the tack.There was no additional intervention required and no patient injury reported.This product problem is being submitted because the tack migrated.There is potential for harm if it were to recur.
Additional Manufacturer Narrative
Block h3: the tes device was discarded by the facility, thus no returned product investigation was performed.Block h6: ifu intended use: -tack is indicated for use in the sfa and proximal pop arteries, and not indicated for use in the common femoral artery.Ifu warning/precautions: -avoid moving tack catheter through already deployed tack implants when possible.-failure to perform a post tack implant balloon inflation may result in inadequate tissue apposition and/or inability to seat the anchors.-tack implant may cause distal embolization or migration from the site.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: TACK ENDOVASCULAR SYSTEM (6F, 4.0-8.0MM)
• Common Device Name: SCAFFOLD, DISSECTION REPAIR
• Manufacturer (Section D): INTACT VASCULAR, INC.; 5905 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): INTACT VASCULAR, INC.; 5905 nathan lane north; plymouth MN 55442
• Manufacturer Contact: ana tan ; 5905 nathan lane north; plymouth, MN 55442 ; 858720-4037
• MDR Report Key: 19667677
• Report Number: 3012608866-2024-00013
• Device Sequence Number: 17828880
• Product Code: QCT
• UDI-Device Identifier: 00850003494036
• UDI-Public: (01)00850003494036
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 206135061
• Device Catalogue Number: 206135061
• Device Lot Number: 249493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.035" GUIDEWIRE, MFG UNK.; COOK: 6F INTRODUCER SHEATH.
• Patient Sex: Unknown