MAUDE Adverse Event Report: INTACT VASCULAR INC. TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM)

Model Number 6F

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to intact vascular at the time of this report and is not expected to be returned.Intact vascular has attempted to contact the reporter of this event for additional information.If additional information is received after this report, a supplemental report will be submitted.

Event Description

Non-compliant patient underwent multiple endovascular interventions.Tack implantation procedure occurred on (b)(6) 2020.This procedure was performed 12 months post atherectomy and dcb intervention as patient returned with recurrent symptoms.Patient received 9 (nine) tack implants and end result of the procedure showed dissections treated with good flow.Patient returned 7.5 months later on (b)(6) 2020 with symptomatic pain and was found to have the prior treated superior femoral artery (sfa) occluded including the tack implanted region (distal sfa to p2).Physician observed the patient was still non-compliant (continued smoking and not taking prescribed medication).Physician decided to perform another endovascular procedure and used penumbra cat 8 & 6 devices and followed with use of angiojet and ended the procedure with use of medtronic se stent over all tack implants.At the end of the procedure, one out of the nine tack implants was observed to be displaced in anterior tibial region.Physician concluded the procedure stating, no further intervention necessary.Patient did not experience any adverse events and is viable for future femoral/tibial bypass procedure options.

• Brand Name: TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM)
• Type of Device: TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM)
• Manufacturer (Section D): INTACT VASCULAR INC.; 1285 drummers lane; suite#200; wayne PA 19087
• Manufacturer Contact: ms. joshi ; 1285 drummers lane; suite 200; wayne, PA 19087 ; 4842531048
• MDR Report Key: 10614092
• MDR Text Key: 209423492
• Report Number: 3012608866-2020-00003
• Device Sequence Number: 1
• Product Code: QCT
• UDI-Device Identifier: 00863328000103
• UDI-Public: 00863328000103
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6F
• Device Catalogue Number: 156120061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: No
• 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: ANGIO-JET; CHOCOLATE PTA (3.5 & 5.0MM); INPACT DCB (5.0&6.0MM); MEDTRONIC STENT SE; PENUMBRA CAT 8.0 & 6.0
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR