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	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2021
Type of Reportable Event	Malfunction
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: the tack device with five fully expanded tack components were returned for evaluation.Additionally, it was noted that the hemostatic valve was returned in the locked position.Visual inspection found a damaged (kinked and twisted) shaft and lumen.During functional testing, an attempt was made to pin and pull the device to insert and withdraw the outer sheath but was unsuccessful; signaling the hemostatic valve was functioning appropriately.Block h6: based on the device evaluation, a possible root cause may be due to improperly locking the hemostatic valve prior to device withdrawal.The ifu warns that failure to tighten (lock) the hemostatic valve prior to repositioning the delivery system could result in inadvertent deployment of additional tack implant(s).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 in a peripheral procedure.During use, one tack was deployed successfully in the popliteal artery.The physician planned to deploy additional tacks in the other areas of the sfa, which required the device to be removed from the patient in order to reposition.As the device was being pulled over the wire outside of the patient's body, the outer sheath retracted, and unintentionally deployed the remaining 5 tacks.The procedure was completed using a regular stent to treat the sfa.No patient injury reported.This product problem is being submitted because the tack inadvertently deployed.There is potential for harm if it were to recur.

• 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: 19665820
• Report Number: 3012608866-2024-00002
• Device Sequence Number: 6904742
• Product Code: QCT
• UDI-Device Identifier: 00850003494036
• UDI-Public: (01)00850003494036
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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: 03/26/2023
• Device Model Number: 206135061
• Device Catalogue Number: 206135061
• Device Lot Number: 253315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2021
• 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