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

Model Number 156135061

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2023

Event Type  Injury  

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 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
• Type of Device: 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 ; 719377-898
• MDR Report Key: 16678142
• MDR Text Key: 312673190
• Report Number: 3012608866-2023-00001
• Device Sequence Number: 1
• Product Code: QCT
• UDI-Device Identifier: 00863328000127
• UDI-Public: 00863328000127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6F GUIDE CATHETER UNK MFG; 6F INTRODUCER SHEATH UNK MFG; PHILIPS: 0.014" PHOENIX GUIDEWIRE
• Patient Outcome(s): Required Intervention