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

Model Number	206135061
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The tack endovascular system (tes) was used to treat the slightly tortuous and moderately calcified peripheral lesions.Four tacks were deployed successfully.During removal, it was noted that the distal portion of the inner core separated inside the introducer sheath.The introducer sheath was removed with the separated tes contained within the sheath.Imaging confirmed no piece was retained inside the body.The same introducer sheath was placed back inside the patient to complete the procedure.No patient injury reported.This product problem is being submitted due to the shaft separation.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.The tack device was infectious and discarded by the facility, thus no returned product investigation was performed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Additional Manufacturer Narrative
Blocks d1/ g1: manufacturer address was updated from 1285 drummers lane, suite 200, wayne, pa 19087 to 5905 nathan lane north, plymouth, mn 55442.This correction was made to align the address with the fda registration number.
Additional 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.

• Brand Name: TACK ENDOVASCULAR SYSTEM
• Common Device Name: SCAFFOLD, DISSECTION REPAIR
• Manufacturer (Section D): INTACT VASCULAR, INC.; 5905 nathan lane north; suite 200; plymouth MN 19087
• Manufacturer (Section G): INTACT VASCULAR; 5905 nathan lane north; suite 200; plymouth MN 19087
• Manufacturer Contact: diana melliza galvez ; 5905 nathan lane north; suite 200; plymouth, MN 55442
• MDR Report Key: 15813490
• Report Number: 3012608866-2022-00002
• Device Sequence Number: 17896314
• Product Code: QCT
• UDI-Device Identifier: 00850003494036
• UDI-Public: 00850003494036
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P180034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2022
• Device Model Number: 206135061
• Device Catalogue Number: 206135061
• Device Lot Number: 245675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 10/25/2022; 10/25/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 05/19/2023; 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.018" GUIDE WIRE, UNK MFG.; TERUMO: 6F PINNACLE DESTINATION SHEATH.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White