MAUDE Adverse Event Report: INTACT VASCULAR TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM); SCAFFOLD, DISSECTION REPAIR

Catalog Number 156135061

Device Problem Off-Label Use (1494)

Patient Problem Thrombus (2101)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to intact vascular at the time of this report and is not expected to be returned.If additional information is received after this report, a supplemental report will be submitted.There is no conclusive evidence at this time that the tack implant contributed to the occlusion.

Event Description

Right limb p2/p3 observed to be occluded 1-week post dissection repair using tack endovascular system (6f, 3.5-6.0mm).On (b)(6) 2020, physician implanted 6 tacks (6f tack endovascular system (6f, 3.5-6.0mm)lot# 206193)in patient's right limb (p2/p3) to repair post pta observed dissection.Note: 6f tack endovascular system (6f, 3.5-6.0mm) is indicated for use in superficial femoral artery (sfa) and proximal popliteal (p1) region.Use of the device within p2/p3 was used off-label by physician at their discretion and without any on-site intact vascular sales team support.On (b)(6) 2020 (one week post initial intervention), the physician was performing a previously scheduled intervention on the patient's left limb, a right limb runoff was also performed and occlusion observed within the tack implanted p2/p3 region (the tack implants were deployed one week prior during the procedure that occurred on (b)(6) 2020).Intact vascular was notified about the adverse event "occlusion within implanted tacks region" on (b)(6) 2020.Patient was scheduled to return to treat occlusion on (b)(6) 2020.During the re-intervention to resolve the observed occlusion, laser artherectomy was performed by the physician and the occlusion was resolved and blood flow restored.This event is being reported as additional intervention was performed to treat the observed obstruction of the vessel in the tack implant section of p2/p3 to restore flow.There is no conclusive evidence at this time that the tack implant contributed to the occlusion.No further adverse events have been reported to intact vascular since the re-intervention performed on (b)(6) 2020.

• Brand Name: TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM)
• Type of Device: SCAFFOLD, DISSECTION REPAIR
• Manufacturer (Section D): INTACT VASCULAR; 1285 drummers lane; suite 200; wayne, pa
• Manufacturer Contact: joseph griffin iii ; 1285 drummers lane; suite 200; wayne, pa ; 2531048
• MDR Report Key: 9898387
• MDR Text Key: 196628886
• Report Number: 3012608866-2020-00001
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2020

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 Catalogue Number: 156135061
• Device Lot Number: 206193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2019
• 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
• Patient Outcome(s): Required Intervention