MAUDE Adverse Event Report: INTACT VASCULAR TACK ENDOVASCULAR SYSTEM (6F, 4.0 - 8.0MM)

Model Number	6F
Medical Device Problem Codes	Unintended Collision (1429); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not being returned to intact vascular for evaluation as the implants were discarded at the hospital.If any additional information regarding this event becomes available, intact vascular will submit a 3500a supplemental report accordingly.
Event or Problem Description
Five 4-8mm tacks were placed in proximal/mid sfa around (b)(6) 2021.Patient had been on dual antiplatet therapy from prior procedure.Initial angiogram showed patent tacks and sfa, with a long dissection present in distal sfa/proximal popliteal.We then used 0.014 ivus to evaluate dissections, vessel size, disease burden/morphology, in popliteal, as physician pre-procedure had planned on stenting with supera stent in pop and eluvia in sfa if needed.Ivus showed soft eccentric plaque in popliteal around 80% stenosis.There was also a long dissection plane from proximal popliteal into distal sfa, as well as some other areas of dissection throughout the sfa.Physician wanted to use hawk atherectomy for popliteal.Advised physician to proceed with caution through tacks since somewhat recent placement, and that the hawk may be to "bulky" to pass through two of the proximal tacks that weren't fully expanded due to some residual disease.Spider filter/wire was placed into the distal popliteal and then hawk inserted.At one point physician had some difficulty passing hawk in sfa.After three passes with the hawk, it was removed, and physician requested a stellarex for the popliteal.No issues with passing and inflating stellarex noted.After dcb a supera stent was inserted, and when physician panned down to popliteal to do angiogram for stent placement it was noticed that two tacks were dislodged from the sfa into the popliteal just above the filter.Physician attempted to use an 0.035 quick cross catheter to retrieve the filter, but that just pushed the tacks onto the filter, at which time they became entangled with the filter.Eventually physician up sized to 8f sheath and used the snare to retrieve the tacks and the filter wire.After tacks and filter retrieved, physician proceeded with his plan of stenting the popliteal.He then ballooned the sfa with a 7mm balloon, including the areas of the three remaining tacks, and placed the three eluvia stents in the sfa.Post procedure it was noted that one of the tacks on the spider wire was "crushed" and entangled with the other tack.Physician was satisfied no patient harm was done, and other that having to snare the tacks and filter, he did not need to perform any additional or unexpected procedures during the case.

• Brand Name: TACK ENDOVASCULAR SYSTEM (6F, 4.0 - 8.0MM)
• Common Device Name: TACK ENDOVASCULAR SYSTEM (6F, 4.0 - 8.0MM)
• Manufacturer (Section D): INTACT VASCULAR; 1285 drummers lane; suite #200; wayne PA 19087
• Manufacturer (Section G): INTACT VASCULAR, INC.; 1285 drummers lane; suite #200; wayne PA 19087
• Manufacturer Contact: ryan gernatt ; 1285 drummers lane; suite #200; wayne, PA 19087 ; 6102076878
• MDR Report Key: 12862680
• Report Number: 3012608866-2021-00004
• Device Sequence Number: 11782309
• Product Code: QCT
• UDI-Device Identifier: 00850003494036
• UDI-Public: 00850003494036
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P180034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6F
• Device Catalogue Number: 206135061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.014 IVUS; 6F COOK ANSEL SHEATH 55CM; 6MM SPIDER FITER WIRE; MEDTRONIC HAWK LS-M; STELLAREX 6MMX150MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male