MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10604
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Respiratory Distress (2045); Tachycardia (2095); Heart Failure (2206); Stenosis (2263)
Date of Event	01/01/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is combination product.
Event or Problem Description
(b)(6) study.It was reported that arterial hypotension, in-stent restenosis and cardiac arrest which led to death occurred.On (b)(6) 2017, the patient was referred for elective cardiac catheterization.The target lesion was 95% stenosed, 20 mm long with a reference vessel diameter of 2.5 mm located in the first obtuse marginal artery (om1).The target lesion was treated with direct placement of a 2.50 x 24 mm study stent with 0% residual stenosis.The patient was discharged on dual antiplatelet therapy (aspirin and clopidogrel).On (b)(6) 2018, the patient experienced chest pain due to chronic polymyalgia rheumatica and pulmonary embolism.On (b)(6) 2018, the patient was hospitalized due to arterial hypotension and was treated with medication.On the same day, the patient was also diagnosed with in-stent restenosis in the first obtuse marginal artery (om1) and had "an" elevated troponin levels but did not meet criteria of myocardial infarction (mi).Eight days later, the patient was treated with medications in response to om1 in-stent restenosis and elevated troponin level.The patient was not a good candidate for coronary artery bypass grafting (cabg) surgery and percutaneous coronary intervention (pci) was particularly not feasible to any coronary artery.Additionally, the in-stent restenosis was only a diagnosis.The patient was discharged two days later from the hospital on aspirin and clopidogrel.On (b)(6) 2019, the patient presented in emergency department for the evaluation of dyspnea.An ekg revealed sinus tachycardia with premature ventricular complexes.The patients family stated that the patient had been suffering from shortness of breath for several days but condition had worsened over the last 24 hours.On physical examination, the patient was noted to be in severe respiratory distress and in tachycardia state.In emergency "the" department, the patient was diagnosed with cardiac arrest and acute on chronic systolic (congestive heart failure).The patient was treated with medication in response to the events.The patient and the family did not want any aggressive treatment further and hence, the patient was on a do not resuscitate (dnr) as per the patient and "families" request.The patient then expired.The cause of death was acute on chronic systolic heart failure and cardiac arrest.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8286295
• Report Number: 2134265-2019-00347
• Device Sequence Number: 1947190
• Product Code: NIQ
• UDI-Device Identifier: 08714729840213
• UDI-Public: 08714729840213
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

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: 03/14/2018
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0020447537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 01/29/2019
• 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: Death
• Patient Age: 78 YR