Upon removal of the stellarex device, embolus and bleeding were noted, thus additional intervention was required.This is being reported as part of the clinical study.The drug information is noted below: stellarex 0.035 otw drug-coated angioplasty balloon; paclitaxel drug, 2.6 mg; therapy date: (b)(6) 2017; adjunct to pta in the treatment of denovo or post pta occluded/ stenotic or restenotic lesions (excluding in-stent) in fem-pop arteries.Lot #: ffv17a06a.Expiration date: 01/26/2019.(b)(4).Pma number is not applicable.The device has a ce mark that was used in an investigational application./ combination product is applicable.The device was not returned, thus no product evaluation was performed.Per the ifu, embolism and bleeding are listed as a potential complications/adverse events.
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On (b)(6) 2017, the patient underwent an index procedure of a 290 mm, 90% stenotic de novo lesion of the left proximal, mid and distal sfa.The lesion was predilated using a 4 x 150 mm balloon and inflated to 20 atm, resulting in a residual 50% stenosis.Next, a 5 x 120 mm stellarex balloon was inflated to 16 atm for 3 minutes, resulting in a residual 0% stenosis.Then, a 5 x 120 mm stellarex balloon was inflated to 16 atm for 3 minutes, resulting in a residual 0% stenosis.After, a 5 x 80 mm stellarex balloon was inflated to 18 atm for 3 minutes, resulting in a residual 0% stenosis.Post index procedure, an embolus was noted on the images in the popliteal trifurcation.The clot was successfully retrieved percutaneously with 3 vessel run off.In addition, the patient was bleeding from the groin puncture site, thus 1 suture was applied.The patient was discharged on (b)(6) 2017.The surgeon indicated the incident is highly probably related to the study device and procedure.
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