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

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.

• 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 Key: 12962507
• MDR Text Key: 285242880
• Report Number: 3012608866-2021-00006
• Device Sequence Number: 1
• Product Code: QCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180034
• Number of Events Reported: 1
• 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 Received: 12/08/2021
• Supplement Dates Manufacturer Received: 11/09/2021; 11/09/2021
• Supplement Dates FDA Received: 05/19/2023; 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 Number: 1
• Treatment: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention