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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTACT VASCULAR INC. TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM)

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INTACT VASCULAR INC. TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM) Back to Search Results
Model Number 6F
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Pain (1994)
Event Date 08/24/2020
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to intact vascular at the time of this report and is not expected to be returned. Intact vascular has attempted to contact the reporter of this event for additional information. If additional information is received after this report, a supplemental report will be submitted.
 
Event Description
Non-compliant patient underwent multiple endovascular interventions. Tack implantation procedure occurred on (b)(6) 2020. This procedure was performed 12 months post atherectomy and dcb intervention as patient returned with recurrent symptoms. Patient received 9 (nine) tack implants and end result of the procedure showed dissections treated with good flow. Patient returned 7. 5 months later on (b)(6) 2020 with symptomatic pain and was found to have the prior treated superior femoral artery (sfa) occluded including the tack implanted region (distal sfa to p2). Physician observed the patient was still non-compliant (continued smoking and not taking prescribed medication). Physician decided to perform another endovascular procedure and used penumbra cat 8 & 6 devices and followed with use of angiojet and ended the procedure with use of medtronic se stent over all tack implants. At the end of the procedure, one out of the nine tack implants was observed to be displaced in anterior tibial region. Physician concluded the procedure stating, no further intervention necessary. Patient did not experience any adverse events and is viable for future femoral/tibial bypass procedure options.
 
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Brand NameTACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM)
Type of DeviceTACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM)
Manufacturer (Section D)
INTACT VASCULAR INC.
1285 drummers lane
suite#200
wayne PA 19087
Manufacturer Contact
ms. joshi
1285 drummers lane
suite 200
wayne, PA 19087
4842531048
MDR Report Key10614092
MDR Text Key209423492
Report Number3012608866-2020-00003
Device Sequence Number1
Product Code QCT
UDI-Device Identifier00863328000103
UDI-Public00863328000103
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6F
Device Catalogue Number156120061
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/01/2020 Patient Sequence Number: 1
Treatment
ANGIO-JET; CHOCOLATE PTA (3.5 & 5.0MM); INPACT DCB (5.0&6.0MM); MEDTRONIC STENT SE; PENUMBRA CAT 8.0 & 6.0
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