MAUDE Adverse Event Report: INTACT VASCULAR, INC. TACK ENDOVASCULAR SYSTEM; SCAFFOLD, DISSECTION REPAIR

Model Number	156135061
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient''s dob or age at time of event, weight, ethnicity, and race are unknown.This information was not available from the facility.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.The tack device was discarded by the facility, thus no returned product investigation was performed.Based on the complaint details, the user failed to follow the ifu.The ifu warns that failure to perform a post tack implant balloon inflation may result in inadequate tissue apposition and/or inability to seat the anchors.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.
Event or Problem Description
The tack endovascular system (tes) was used to treat a slightly calcified soft tissue in the tibioperoneal trunk (tp).The first tack was deployed in the distal tp at the origin of the occluded posterior tibial artery.The second tack was deployed in the middle tp, and the third tack went in to the proximal tp at the origin of the anterior tibial artery.Angiogram showed a residual dissection between the second and third tack.Without post dilating, a forth tack was deployed between the second and third tack to treat the residual dissection.However, as the physician was maneuvering the delivery system through the third tack, it got caught and malformed the tacks.A bailout stent was placed to complete the procedure.No patient injury reported.This adverse event is being submitted due to a bailout stent required to complete the procedure.

• Brand Name: TACK ENDOVASCULAR SYSTEM
• Common Device Name: SCAFFOLD, DISSECTION REPAIR
• Manufacturer (Section D): INTACT VASCULAR, INC.; 5905 nathan ln n; plymouth MN 55442
• Manufacturer (Section G): INTACT VASCULAR; 5905 nathan ln n; plymouth MN 55442
• Manufacturer Contact: diana melliza galvez ; 5905 nathan ln n; plymouth, MN 55442 ; 719377-8986
• MDR Report Key: 16678142
• Report Number: 3012608866-2023-00001
• Device Sequence Number: 12099089
• Product Code: QCT
• UDI-Device Identifier: 00863328000127
• UDI-Public: 00863328000127
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P180034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2023
• Device Model Number: 156135061
• Device Catalogue Number: 156135061
• Device Lot Number: 275842
• 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: Not provided
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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: 6F GUIDE CATHETER UNK MFG; 6F INTRODUCER SHEATH UNK MFG; PHILIPS: 0.014" PHOENIX GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown