Device is a combination product.Device evaluated by mfr.: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
|
Same case as mdr id: 2134265-2017-12494.(b)(6).It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2012, the patient was presented with a single episode of chest discomfort and strong family history of coronary artery disease.Coronary angiography and index procedure were then performed.The target lesion was a de novo lesion located in the proximal left circumflex(lcx) with 60% stenosis and was 8mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with direct placement of 3.00x12mm promus element¿ plus stent resulting in 0% residual stenosis.Target lesion #2 was a de novo lesion located in the mid-distal lcx with 90% stenosis and was 8mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with direct placement of a 3.00x8mm promus element¿ plus stent resulting in 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient was presented to the emergency room with unstable angina and 2 day history of intermittent chest pain.The patient developed anterior chest wall "tightness" with no radiation of symptoms and had taken nitroglycerine in response to that, which relieved his symptoms.On the same day, the patient was admitted to the hospital.Patient's troponin cardiac enzyme to be negative, which continued to trend and patient was ruled out for acute coronary syndrome.Coronary angiography was performed and revealed 80-90% proximal isr and 80% mid vessel isr of previously placed 3.00x12mm and 3.00x8mm promus element¿ plus stents.Six days from admission, the 80-90% proximal isr and 80% mid vessel isr of previously placed study stents were treated with reverse saphenous graft to terminal circumflex.On the same day, the 80% stenosis in mid right coronary artery (rca) and 70% stenosis in mid left anterior descending (lad) were treated by reverse saphenous vein graft to rca and left internal mammary artery to mid distal portion of the lad respectively.Five days post procedure, the patient was seen and evaluated by a cardiologist and the event was considered to be resolved.The patient was then discharged on aspirin and clopidogrel.
|