Same case as mdr id: 2134265-2015-02007 and 2134265-2015-02008.(b)(4) clinical study.It was reported that angina, atherosclerosis and in-stent restenosis (isr) occurred.In (b)(6) 2012, the patient presented due to unstable angina.Following day, the coronary angiography and index procedure were performed respectively.The target lesion was located in first obtuse marginal (om1) with 90% in-stent restenosis and was 6.0 mm long with a reference vessel diameter of 3.00 mm.The lesion was treated with direct stent placement using a 3.00 x 8.00 mm promus element¿ plus stent, resulting with 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the 2.25 x 16 mm promus premier¿ stent was implanted in the om1.In (b)(6) 2014, the 2.5 x 16 mm promus element plus stent was implanted in the middle of left circumflex (lcx).In (b)(6) 2015, the patient presented with one week history of recurrent chest and mid-back discomfort.The coronary angiography revealed 80% mid stenosis isr of 2.5 x 16 mm promus element plus stent, 80% stenosis om1 isr of study stent as well as the 2.25 x 16 mm promus premier¿ stent.Subsequently, the om1 was treated with balloon angioplasty, resulting with 0% residual stenosis.Additionally, the stenosis in distal lcx was treated with balloon angioplasty with 20% residual stenosis.Also, stenosis in the right posterolateral (rpl) branch was treated with balloon angioplasty with 0% residual stenosis.One day post procedure, the event was considered resolved and the patient was discharged on aspirin and clopidogrel.
|
Device is a combination product.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.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).
|
It was further reported that in (b)(6) 2015, the patient presented emergently due to chest pain and shortness of breath (sob).Subsequently, coronary angiography revealed 90% in-stent restenosis (isr) of 2.5 x 16 mm promus premier stent (commercial product) in distal portion; 80% isr of study stent and of 2.25 mm promus premier stent (commercial product) in om1.The 90% isr in distal left circumflex (lcx) was treated with direct stent placement using a 2.5mm x 20mm promus drug-eluting stent, resulting to 0% residual stenosis.
|