MAUDE Adverse Event Report: INTACT VASCULAR, INC. TACK ENDOVASCULAR SYSTEM; SCAFFOLD, DISSECTION REPAIR

Model Number 206135061

Device Problems Retraction Problem (1536); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2022

Event Type  Injury  

Manufacturer Narrative

The patient's dob, age at time of event, weight, ethnicity, and race are unknown.This information was not available from the facility.Patient information regarding relevant tests/laboratory data or medical history are unknown.The information was not available from the facility.The tes device has not been returned by the facility, thus no returned product investigation was performed.The ifu warnings and pre-cautions states: do not use excessive force when using this device as this could result in damage to the device, including component fracture.

Event Description

The tes device was used to treat a dissection in a moderately tortuous and slightly calcified mid sfa.During delivery, resistance was noted and force was applied, but was unable to reach the target lesion.During removal, resistance was noted and force was applied to remove the device.Upon removal, it was observed that the tip had separated inside the patient.The tip was unable to be retrieved; therefore, the physician placed a stent over the tip.The patient was doing ok post procedure and was discharged according to plan.This adverse event and product problem is being submitted due to the device fragment left in the patient, resulting in additional intervention.

Manufacturer Narrative

Block b1/h1: based on the returned product evaluation, this is no longer reportable for both an adverse event and product problem.Block d9/g3: the tack endovascular system (tes) device was returned for evaluation.Block h3: visual inspection found the inner core shaft located on the proximal end of the device was excessively withdrawn past the most proximal inner core marker, thus the white distal tip was not visible past the distal end of the outer braided sheath.During functional testing, the tacks were unable to be deployed, which indicates that excessive force was applied by the user during the pin and pull deployment method.The device was dissected to reveal the white distal tip, inner core shaft, distal inner core markers, and 6 tacks were present and visible.Block h6: it appears that the tack deployment process (pin/pull technique) was incorrectly performed.The tip was present (not detached), but was incorrectly withdrawn into the braided outer sheath.Step 10 of ifu states to pin the inner core and pull back on the outer sheath to deploy tacks.However, the user instead pinned the outer sheath and pulled back on the inner core, thus pulling the tip into the outer sheath.Investigation conclusion code: 18 (failure to follow instructions) as reported in the initial mdr remains applicable.Correction: medical device problem code: 1562 (material separation) and health effect clinical code: fda #2687 (foreign body in patient) as reported in the initial mdr is no longer applicable.

Manufacturer Narrative

Block h6: in supplemental #1, it was noted that hecc #2687 (foreign body in patient) was no longer applicable.However, it was inadvertently missed to add a replacement code; therefore, hecc #4582 (no clinical signs, symptoms or conditions) is being added in supplemental #2.

Manufacturer Narrative

Blocks d1/ g1: manufacturer address was updated from 5905 nathan lane north, plymouth, mn 55442 to 1285 drummers lane, suite 200, wayne, pa 19087 to match the information on the product label.

Manufacturer Narrative

Blocks d1/ g1: manufacturer address was updated from (b)(6).This correction was made to align the address with the fda registration number.

• Brand Name: TACK ENDOVASCULAR SYSTEM
• Type of Device: SCAFFOLD, DISSECTION REPAIR
• Manufacturer (Section D): INTACT VASCULAR, INC.; 5905 nathan lane north; suite 200; plymouth MN 19087
• Manufacturer (Section G): INTACT VASCULAR, INC.; 5905 nathan lane north; suite 200; plymouth MN 19087
• Manufacturer Contact: ana tan ; 5905 nathan lane north; suite 200; plymouth, MN 55442
• MDR Report Key: 13476954
• MDR Text Key: 289460283
• Report Number: 3012608866-2022-00001
• Device Sequence Number: 1
• Product Code: QCT
• UDI-Device Identifier: 0850003494036
• UDI-Public: 010850003494036
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2023
• Device Model Number: 206135061
• Device Catalogue Number: 206135061
• Device Lot Number: 251973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 03/08/2022; 03/08/2022; 03/08/2022; 03/08/2022
• Supplement Dates FDA Received: 03/08/2022; 03/08/2022; 05/19/2023; 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2021
• 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: COOK: ROADRUNNER GUIDEWIRE, SIZE UNK.; MERIT: 6F PRELUDE IDEAL INTRODUCER SHEATH.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female