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.
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