MAUDE Adverse Event Report: INTACT VASCULAR, INC. TACK ENDOVASCULAR SYSTEM (6F, 4.0 - 8.0MM); TACK ENDOVASCULAR SYSTEM (6F, 2.0 - 8.0MM)

Model Number	6F
Medical Device Problem Codes	Unintended Collision (1429); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not being returned to intact vascular for evaluation as it remains implanted in the patient.If any additional information regarding this event becomes available, intact vascular will submit a 3500a supplemental report accordingly.
Event or Problem Description
Upon post dilation of the tacks, the balloon passed the first tack without issue but came into contact with the second tack.The balloon became caught on the second tack.The balloon pushed the tack sideways in the vessel and then down the superficial femoral artery (sfa).Eventually, the operator was able to use a stent to overlay the displaced tack, securing it against the vessel wall.A self-expanding stent was placed in the proximal sfa to cover the dissections.At the conclusion of the procedure, there was complete flow through the sfa.

• Brand Name: TACK ENDOVASCULAR SYSTEM (6F, 4.0 - 8.0MM)
• Common Device Name: TACK ENDOVASCULAR SYSTEM (6F, 2.0 - 8.0MM)
• Manufacturer (Section D): INTACT VASCULAR, INC.; 1285 drummers lane; suite #200; wayne PA 19087
• MDR Report Key: 12051440
• Report Number: 3012608866-2021-00003
• Device Sequence Number: 11864889
• Product Code: QCT
• UDI-Device Identifier: 00850003494036
• UDI-Public: 00850003494036
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P180034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

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: 11/11/2022
• Device Model Number: 6F
• Device Catalogue Number: 206135061
• Device Lot Number: 243668
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention