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U.S. Department of Health and Human Services

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

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INTACT VASCULAR, INC. TACK ENDOVASCULAR SYSTEM; SCAFFOLD, DISSECTION REPAIR Back to Search Results
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h3: visual inspection found the inner core shaft located on the proximal end of the device was excessively withdrawn past the most proximal inner core marker, thus the white distal tip was not visible past the distal end of the outer braided sheath.During functional testing,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.
 
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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 Key13476954
MDR Text Key289460283
Report Number3012608866-2022-00001
Device Sequence Number1
Product Code QCT
UDI-Device Identifier0850003494036
UDI-Public010850003494036
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180034
Number of Events Reported1
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 Date02/09/2023
Device Model Number206135061
Device Catalogue Number206135061
Device Lot Number251973
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/14/2022
Initial Date FDA Received02/07/2022
Supplement Dates Manufacturer Received03/08/2022
03/08/2022
03/08/2022
03/08/2022
Supplement Dates FDA Received03/08/2022
03/08/2022
05/19/2023
08/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
COOK: ROADRUNNER GUIDEWIRE, SIZE UNK.; MERIT: 6F PRELUDE IDEAL INTRODUCER SHEATH.
Patient Outcome(s) Required Intervention;
Patient SexFemale
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