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	H7493926020270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Fatigue (1849); Occlusion (1984)
Date of Event	10/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Complainant name: (b)(6) hosp.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) study.It was reported that restenosis occurred.In (b)(6) 2016, the patient presented with unstable angina (braunwald classification: iiib) and was referred for cardiac catheterization.The target lesion was located in the mid left anterior descending artery (lad) with 90% stenosis and was 16mm long with a reference vessel diameter of 2.75mm.The target lesion was treated with pre-dilatation and placement of a 2.75mm x 20mm study stent with 0% residual stenosis.The following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient visited the study hospital reporting intermittent palpitations, substernal chest pressure (nitroglycerin 5-6 times over last month) and was in sinus.The patient also reported increasing fatigue over the last 6 months.In (b)(6) 2017, the patient presented with chest pain and abnormal stress test.The patient was hospitalized for scheduled cardiac catheterization.Coronary angiography revealed 80% stenosis in mid lad, immediately prior to the study stent which was open.The 80% stenosis at mid lad was treated with 3.0x16mm synergy stent implanted within 5mm of the study stent.Post-dilatation the residual stenosis was 0%.The proximal lad also had revascularization.The following day, the event was considered as resolved and the subject was discharged on the same day.

• 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: 7136283
• Report Number: 2134265-2017-12534
• Device Sequence Number: 10786523
• Product Code: NIQ
• UDI-Device Identifier: 08714729840169
• UDI-Public: 08714729840169
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/30/2017

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: 05/17/2017
• Device Model Number: H7493926020270
• Device Catalogue Number: 39260-2027
• Device Lot Number: 0019297665
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/20/2017
• 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: 81 YR