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

Device Problems Unintended Collision (1429); Device Damaged by Another Device (2915)

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

Event Date 06/09/2021

Event Type  malfunction  

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 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)
• Type of Device: TACK ENDOVASCULAR SYSTEM (6F, 2.0 - 8.0MM)
• Manufacturer (Section D): INTACT VASCULAR, INC.; 1285 drummers lane; suite #200; wayne PA 19087
• Manufacturer (Section G): INTACT VASCULAR, INC.; 1285 drummers lane; suite #200; wayne PA 19087
• Manufacturer Contact: kimberly mcgill ; 1285 drummers lane; suite #200; wayne, PA 19087 ; 4842531048
• MDR Report Key: 12051440
• MDR Text Key: 278398080
• Report Number: 3012608866-2021-00003
• Device Sequence Number: 1
• Product Code: QCT
• UDI-Device Identifier: 00850003494036
• UDI-Public: 00850003494036
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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
• Patient Outcome(s): Required Intervention