MAUDE Adverse Event Report: INTACT VASCULAR, INC. TACK ENDOVASCULAR SYSTEM (6F, 4.0-8.0MM); SCAFFOLD, DISSECTION REPAIR

Model Number	206135061
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a: the patient's dob or age at time of event, sex, gender, weight, ethnicity, and race are unknown.Block b6/b7: patient information regarding relevant tests/laboratory data or medical history are unknown.Block h3/h6: the tack device was not returned, 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.
Event or Problem Description
The tack endovascular system (tes) was used to treat the sfa lesion.Three tacks were deployed inside the patient; however, one tack was slightly tilted.In order to achieve the desired outcome, the physician elected to stent the most distal tack, even though leaving it slightly tilted in place was not expected to cause any risk or harm to the patient.No patient injury reported.This adverse event and product problem is being submitted conservatively due to the tack position; resulting in elected stent placement.
Additional Manufacturer Narrative
Block g3: date received by manufacture updated to 6/24/2024 (from 6/24/2023).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
Block d4: unique identifier (udi#) updated to include full udi number.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.

• Brand Name: TACK ENDOVASCULAR SYSTEM (6F, 4.0-8.0MM)
• Common Device Name: SCAFFOLD, DISSECTION REPAIR
• Manufacturer (Section D): INTACT VASCULAR, INC.; 5905 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): INTACT VASCULAR, INC.; 5905 nathan lane north; plymouth MN 55442
• Manufacturer Contact: diana melliza galvez ; 5905 nathan lane north; plymouth, MN 55442 ; 510933-4541
• MDR Report Key: 19696745
• Report Number: 3012608866-2024-00001
• Device Sequence Number: 8009213
• Product Code: QCT
• UDI-Device Identifier: 00850003494036
• UDI-Public: (01)00850003494036(17)230413(10)253321
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: 206135061
• Device Catalogue Number: 206135061
• Device Lot Number: 253321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 06/26/2024; 07/16/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 07/08/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2021
• 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: UNK MFG AND SIZE: GUIDE CATHETER.; UNK MFG AND SIZE: GUIDE WIRE.; UNK MFG AND SIZE: INTRODUCER SHEATH.
• Patient Sex: Unknown