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

Model Number	10606
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiopulmonary Arrest (1765); Death (1802)
Date of Event	06/07/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
(b)(4).It was reported that a death had occurred.In (b)(6) 2017, the subject presented with stable angina and was referred for cardiac catheterization.Target lesion #1 was located in mid left anterior descending artery with 80% stenosis and was 28 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with direct placement of a 2.50 x 32 mm study stent.Following post-dilatation there was 1% residual stenosis and the subject was discharged on dual antiplatelet therapy.In (b)(6) 2018 the subject presented to emergency department with the complaint of chest pain.Per medical personnel, the subject was hypertensive and felt nauseous which was treated with zofran and aspirin following which some improvement was noted.The subject found somnolent and evaluation was recommended.A cat scan of the head was performed and revealed a prominent intraparenchymal hematoma in the right external capsule.There was extensive subarachnoid hemorrhage in the frontal, parietal and temporal as well as left frontal and temporal regions.Subarachnoid hemorrhage fills the basilar cisterns and sylvain fissures and extended along the clivus inferiorly adjacent to the brainstem and superior cord.A small amount of blood was present layering in the left lateral ventricle.There was right to left midline shift of 3.5 mm.Treatment with keppra 1gm was started and the subject was placed on fentanyl and cardene infusion.Additionally the subject was transfused with three units of packed red blood cells.Chest x-ray revealed no pneumothorax or pleural effusion.A right internal jugular venous access device was present with tip likely in the superior vena cava.The etiology of stroke was hemorrhagic and was diagnosed based upon clinical symptoms and neuroimaging.Later, a right craniotomy was performed to treat cerebral aneurysm.Ten days after the craniotomy, the patient died.The primary cause of death was cardiopulmonary arrest and underlying causes which led to death were subarachnoid hemorrhage and cerebral aneurysm.The manner of death was natural and no autopsy was performed.

• 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: 7992241
• Report Number: 2134265-2018-62128
• Device Sequence Number: 16564532
• Product Code: NIQ
• UDI-Device Identifier: 08714729840336
• UDI-Public: 08714729840336
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/22/2018

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: 08/11/2017
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0019611603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/22/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 59 YR