MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926028270
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Reocclusion (1985)
Date of Event	04/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: the device was not returned 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).
Event or Problem Description
(b)(6).It was reported that myocardial infarction and in-stent restenosis occurred.In (b)(6) 2016, the patient presented with unstable angina and was referred for elective cardiac catheterization.Target lesion #1was located in the distal right coronary artery (rca) with 95% stenosis and was 20mm long with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.75 x 28 mm study stent.Following post-dilatation, residual stenosis was 0%.On the same day, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2017, the patient was admitted due to worsening congestive heart failure, considered not related to the study device, and treated with medications.Stress test showed no ischemia.The patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient again presented to emergency room due to accelerating angina pectoris for the last few weeks on a daily basis and with any activity.The patient was noted to have elevated troponin with worsening chest pain, and atrial fibrillation with fast ventricular response.The patient was hospitalized on the same day.On admission, cardiac examinations revealed shortness of breath and chest pain.The patient underwent nitroglycerin drip in response to chest pain.His chest pain got improved with medications and nitroglycerin but not resolved.The patient was suspected to be ischemic once again and due to some ongoing chest pain for an hour, the patient was urgently recommended for cardiac catheterization.The coronary angiography revealed severe 2-vessel disease and ischemic cardiomyopathy with recent decrease in ejection fraction.The patient's urgent myocardial revascularization was delayed because of chronic coumadin management for protein s and c deficiencies, along with plavix management for stents and peripheral vascular disease.Two days later, the patient was electively presented for planned revascularization.The 80% restenosis at origin and mid rca and the 90% focal restenosis present in the study stent deployed at distal rca were treated with coronary artery bypass graft (cabg) performed from reverse saphenous vein graft to the posterior descending artery.Additionally, the cabg was performed from reverse saphenous vein graft to the 1st obtuse marginal (om), in situ left internal mammary artery to mid left anterior descending artery.Post-procedure, the patient was transferred to cardiac intensive care unit, where he recovered relatively quickly.Post-operative, the patient¿s pacemaker was interrogated.Four days later, the patient was diagnosed with pleural effusion which prolonged the hospitalization.Ten days, post-procedure, patient was discharged on aspirin and clopidogrel.The patient was transferred was transferred to rehabilitation hospital for further transitional care unit.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7726693
• Report Number: 2134265-2018-06812
• Device Sequence Number: 11011843
• Product Code: NIQ
• UDI-Device Identifier: 08714729840282
• UDI-Public: 08714729840282
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2016
• Device Model Number: H7493926028270
• Device Catalogue Number: 39260-2827
• Device Lot Number: 0018468288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR