MAUDE Adverse Event Report: INTACT VASCULAR, INC. TACK ENDOVASCULAR SYSTEM® (6F); SCAFFOLD, DISSECTION REPAIR

Catalog Number 156120061

Device Problem Human-Device Interface Problem (2949)

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

The device cannot be returned to the manufacturer because it is permanently implanted in the patient.Intact vascular has attempted to contact the reporter of this event for additional information but the request for additional information was not received.If additional information is received after this report, a supplemental report will be submitted.From the information received to date, it appears that displacement of the implant occurred due to user error.

Event Description

The patient underwent an endovascular procedure around the end of (b)(6) 2019.The tack endovascular system (6f) was used to treat the post-pta dissections observed.Treatment of observed dissections was considered successful at the end of the procedure.This initial intervention was performed by dr.Ehrin armstrong at rocky mountain regional va medical center.One week after the initial endovascular procedure, the patient underwent further treatment unrelated to the use of tack endovascular system.This involved another endovascular procedure where pedal access was used.The physician who performed this second procedure was dr.Javier valle at rocky mountain regional va medical center.The pedal access involved advancing an 0.018" wire and quickcross catheter through the tack implants that were placed a week prior.The crossing of deployed tack implants was done to gain access to the superficial femoral artery (sfa) for further treatment.During the process of crossing the tack implants, the physician displaced the most proximal tack implant against another stent that was placed prior to the second intervention.The resultant displacement of the tack implant was described by the physician (dr.Valle) to cause reduced blood flow.The physician ultimately resolved the issue of reduced blood flow by placing a viabahn stent which covered the displaced tack implant.The final result was considered good and the last known patient condition post-procedure was considered good.This incident is being reported since the previously implanted tack was displaced by the end user (physician) during a secondary intervention that was independent of the tack implant placement.This report is being submitted out of excess caution as the manufacturer has determined that the use of a stent as bailout to treat the reduced bloodflow caused added procedural delay to the medical intervention underway.

• Brand Name: TACK ENDOVASCULAR SYSTEM® (6F)
• Type of Device: SCAFFOLD, DISSECTION REPAIR
• Manufacturer (Section D): INTACT VASCULAR, INC.; 1285 drummers lane, suite 200; wayne PA 19087
• Manufacturer Contact: joseph griffin, iii ; 1285 drummers lane, suite 200; wayne, PA 19087 ; 4842531048
• MDR Report Key: 9321585
• MDR Text Key: 168056142
• Report Number: 3012608866-2019-00001
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 156120061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2019
• 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
• Patient Outcome(s): Required Intervention