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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
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Obstruction/Occlusion (2422)
Event Date 11/01/2020
Event Type  Injury  
Event Description
A 4-8 mm tack device was used to treat a flow limiting dissection in the mid popliteal artery via contralateral approach.The tacks did not appear to fully open; however, post dilated successfully with the same balloon.The physician noted the tacks appeared to land more distal; therefore, two additional tacks were deployed proximal to the others.The same (unwrapped) balloon was used to post dilate and ended up pushing all the tacks downstream.As a result, the tacks bunched up obstructing the blood flow, thus a surgical bypass was created around the tacks.The angiogram was emergently converted to a lower extremity bypass, secondary to severe ischemia / vessel thrombosis.This adverse event and product problem is being submitted due to the bunched tacks obstructing blood flow, requiring surgical intervention (bypass).
 
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 lot number was not available from the facility, thus the following information are unknown: model #, unique id, expiration date, and manufacture date.The tack device was discarded by the facility, thus no returned product investigation was performed.The ifu pre-cautions to use a new balloon catheter for post dilatation of the shortest length possible.
 
Manufacturer Narrative
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 lot number was not available from the facility, thus the following information are unknown: model #, unique id, expiration date, and manufacture date.The tack device was discarded by the facility, thus no returned product investigation was performed.The ifu pre-cautions to use a new balloon catheter for post dilatation of the shortest length possible.
 
Event Description
A 4-8 mm tack device was used to treat a flow limiting dissection in the mid popliteal artery via contralateral approach.The tacks did not appear to fully open; however, post dilated successfully with the same balloon.The physician noted the tacks appeared to land more distal; therefore, two additional tacks were deployed proximal to the others.The same (unwrapped) balloon was used to post dilate and ended up pushing all the tacks downstream.As a result, the tacks bunched up obstructing the blood flow, thus a surgical bypass was created around the tacks.The angiogram was emergently converted to a lower extremity bypass, secondary to severe ischemia / vessel thrombosis.This adverse event and product problem is being submitted due to the bunched tacks obstructing blood flow, requiring surgical intervention (bypass).
 
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.
 
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.
 
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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
diana melliza galvez
5905 nathan lane north
suite 200
plymouth, MN 55442
MDR Report Key12962507
MDR Text Key285242880
Report Number3012608866-2021-00006
Device Sequence Number1
Product Code QCT
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 Other Health Care Professional
Type of Report Initial,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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/09/2021
Initial Date FDA Received12/08/2021
Supplement Dates Manufacturer Received11/09/2021
11/09/2021
Supplement Dates FDA Received05/19/2023
08/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
Patient Outcome(s) Required Intervention;
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