MAUDE Adverse Event Report: INTACT VASCULAR TACK ENDOVASCULAR SYSTEM

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

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

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not being returned to intact vascular for evaluation as the implants remain implanted in the patient.If any additional information regarding this event becomes available, intact vascular will submit a 3500a supplemental report accordingly.

Event Description

On (b)(6) 2021 a tack system was used in in a retrograde fashion, three tacks were deployed, using proper spacing.The operator then wanted to take a final angio and advanced a crossing catheter past the first tack, but not the second one.The catheter snagged a strut, dislodging it into a larger portion of the vessel.The tack seemed well apposed, nothing adverse happened, so the decision was made to bring the patient back and do another angio/ivus.Upon return (09/23/2021) the ivus showed the tack was not fully apposed and needed to have a stent placed inside to allow for a full deployment.Pta was performed and then a supera was placed, when the supera was deployed ita snagged the tack and resulted in it being stretch and turned sideways in the vessel.Another supera was then used in an attempt to jail it again, this time successful.Patient reported as stable following stent bailout with no reported adverse events.

• Brand Name: TACK ENDOVASCULAR SYSTEM
• Type of Device: TACK ENDOVASCULAR SYSTEM
• Manufacturer (Section D): INTACT VASCULAR; 1285 drumers lane; suite #200; wayne PA 19087
• Manufacturer (Section G): INTACT VASCULAR, INC.; 1285 drummers lane; suite #200; wayne PA 19087
• Manufacturer Contact: ryan gernatt ; 1285 drummers lane; suite #200; wayne, PA 19087 ; 6102076878
• MDR Report Key: 12862681
• MDR Text Key: 281159635
• Report Number: 3012608866-2021-00005
• Device Sequence Number: 1
• Product Code: QCT
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 0.018 ADVANTAGE; 5/6 SLENDER SHEATH; IVUS; SUPERA STENT (2 USED)
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Ethnicity: Non Hispanic
• Patient Race: White