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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 Problems Unintended Collision (1429); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 02/17/2021
Event Type  Injury  
Manufacturer Narrative
The device is not being returned to intact vascular for evaluation as it remains implanted in the patient. Intact vascular has requested additional information regarding this event. If additional information is received a supplemental report will be submitted.
 
Event Description
The patient, who was noted to have slightly tortuous vessels, underwent drug coated balloon (dcb) angioplasty guided by intravenous ultrasound (5mmx40mm) in the posterior popliteal and proximal superfiscial femoral artery (sfa). Small dissections were noted in the treatment area prior to drug coated ballooning. Dcb (5x200mm) was performed in the (sfa) and extended the dissections in both the posterior popliteal artery and the proximal sfa. Intact vascular tacks (3. 5-6. 0mm) were placed over the dissections in both the posterior popliteal artery and the proximal sfa. One tack was placed in the posterior popliteal artery and four tacks were placed in the proximal sfa to treat the dissections. All tacks were post-dilated with a 5mm balloon. A subsequent angiogram of the sfa showed the dissection was not resolved. The operating physician opted to perform a subsequent post-dilation with another 5mm balloon. When moving the balloon through the area of the sfa where the four tacks had been placed, the balloon interacted with the third tack as it passed. The third tack was displaced and during the attempt to cross the tack inplant, the third tack got further displaced into the fourth tack and the two tacks became overlapped. The operating physician attempted to resolve the overlapped tacks using a total of six-to-seven balloons. The attempt to resolve the tacks was unsuccessful. In the attempt to resolve the overlapped tacks, all four of the tacks placed in the sfa became overlapped. The operating physician was able to cross a wire behind the overlapped tacks and placed a 6mmx40mm stent over all four tacks to secure against the vessel wall of the proximal sfa. After stenting, a subsequent angiogram revealed full coverage of all tack devices and the dissections. There was no vesicular trauma noted in the sfa or the posterior popliteal artery. The patient was noted to be stable at the close of the procedure.
 
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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
kimberly mcgill
1285 drummers lane
suite #200
wayne, PA 19087
4842531048
MDR Report Key11385374
MDR Text Key233761616
Report Number3012608866-2021-00001
Device Sequence Number1
Product Code QCT
UDI-Device Identifier00863328000127
UDI-Public00863328000127
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,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/13/2022
Device Model Number6F
Device Catalogue Number156135061
Device Lot Number234785
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 Received02/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2020
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: 02/26/2021 Patient Sequence Number: 1
Treatment
1.5X15 MEDTRONIC TEKARU 0.014 BALLOON; 2.5X15 MEDTRONIC TEKARU 0.014 BALLOON; 4.0X20 BOSTON SCIENTIFIC APEX 0.014 BALLOON; 4.0X40X150 ABBOTT ARMADA 0.018 BALLOON; 4.0X60 ABBOTT ARMADA 0.014BALLOON; 4.0X60X150 ABBOTT ARMADA 0.018 BALLOON; 5.5X20 ABBOTT ARMADA 0.014 BALLOON; ELUVIA STENT 6MMX100MM; SPARTACORE 0.014" GUIDE WIRE; STELLAREX DRUG COATED BALLOON 5X200MM; SUPERA STENT 6MMX40MM; TERUMO DESTINATION 6F INTRODUCER SHEATH
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