(b)(4).Device is a combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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It was reported that incomplete stent apposition and stent migration occurred.The target lesion was located in the proximal right coronary artery (prca).A 3.00 x 16 synergy ii drug-eluting stent was advanced to the lesion.As the stent was being deployed at 12 atmospheres, the stent delivery system was accidentally pulled backwards and the stent expanded in the aorta.However, the stent was still encircling the wire on the outside of the guide catheter.It was then decided to pull the stent to the brachial artery.A 6.0x40 non-bsc peripheral vascular stent was then advanced and crushed the 3.00 x 16 synergy ii drug-eluting stent on the brachial artery.Another 3.00 x 16 synergy ii drug-eluting stent was then advanced to the prca and the procedure was completed.No patient complications were reported and the patient's status was fine.
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