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

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.

Manufacturer Narrative

Summary of conclusions from investigation: deployed tacks displaced by ancillary device(s) when attempting to cross over the tacks most likely due to guidewire bias bringing the balloon tip to hit the third tack placed.The tack became caught on the balloon, was displaced, and moved distally.The device operator attempted to move the third tack back into place, re-crossed again but inadvertently moved it distally where it collided with the fourth tack that had been placed.The tacks became overlapped and additional attempts with multiple balloons to secure the overlapped tacks further contributed to the result of all four of the tacks placed in the mid sfa becoming tangled.A wire was finally able to be passed behind the tacks and stents were deployed to secure all tacks against the wall of the artery.The sfa was described by the account representative present at the procedure to be "gnarly" and further noted to be small (5.0mm.) the most probable cause of this event is a combination of difficult vessel and the device operator's choice of ancillary devices.No product was returned for investigation.The tack devices remains implanted in the patient with over-stenting to secure in place in the sfa.

• Brand Name: TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM)
• Type of Device: TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM)
• Manufacturer (Section D): INTACT VASCULAR, INC.; 1285 drummers lane; suite #200; wayne PA 19087
• MDR Report Key: 11385374
• MDR Text Key: 233761616
• Report Number: 3012608866-2021-00001
• Device Sequence Number: 1
• Product Code: QCT
• UDI-Device Identifier: 00863328000127
• UDI-Public: 00863328000127
• Combination Product (y/n): N
• PMA/PMN Number: P180034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2022
• Device Model Number: 6F
• Device Catalogue Number: 156135061
• Device Lot Number: 234785
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• 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; 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR