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

Model Number	10605
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Cardiogenic Shock (2262)
Date of Event	08/28/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
(b)(6) study.It was reported that cardiogenic shock and death occurred.In (b)(6) 2016, due to a clinical status assessment indicating the qualifying condition of unstable angina, the patient was referred for cardiac catheterization.The target lesion was 95% stenosed, 20 mm long with a reference vessel diameter of 2.5 mm located in the distal right coronary artery (rca).The target lesion was treated with pre dilatation and placement of a 2.75 x 28 mm study stent with 0% residual stenosis.The patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient was diagnosed with non-st segment elevation myocardial infarction considered not related to the device.As there were no acute wall motion abnormalities in the distribution of the previously placed bypass grafts, the physician deemed that no coronary angiography was required.Two days later, the ejection fraction was improved from 30% to 50% and wall motion abnormality was consistent with obstruction of the posterior circumflex artery per analysis.The patient had a change in medication dose of isosorbide mononitrate along with reduction of dose in amlodipine during the hospital course.The patient was discharged with dual anti-platelet medications.Twenty days later the patient was hospitalized due to cardiogenic shock.On the same day, the patient expired.The cause of death was cardiogenic shock.It was unknown whether an autopsy was performed or not.

• 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: 8417572
• Report Number: 2134265-2019-02362
• Device Sequence Number: 11210033
• 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): 03/13/2019

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: 09/23/2016
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0018468288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/13/2019
• 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: 64 YR