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

Model Number	10607
Medical Device Problem Codes	Obstruction of Flow (2423); Activation Failure (3270)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Reocclusion (1985); Heart Failure (2206)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
(b)(6) clinical study.It was reported that insufficient stent apposition and in-stent restenosis occurred.In (b)(6) 2018, the patient presented with stable angina.The index procedure was performed the same day.Target lesion was in the mid right coronary artery (rca) extending to distal rca with 95% stenosis and was 70 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 38 mm and 2.75 x 32 mm synergy stents followed by post-dilatation with 0% residual stenosis.On the same day, optical coherence tomography (oct) was performed and revealed stent malposition in focal areas throughout the stent which was additionally post dilated with a 3.25 nc balloon distally and with a 3.5 mm nc balloon proximally.Final oct angiogram revealed well opposed stent and no residual stenosis with timi 3 flow.In (b)(6) 2018, the patient presented with complaints of recurrent exertional chest pain which resolved with rest but required nitroglycerin occasionally.The symptoms increased in the past three months.The patient also complained of chest pressure and shortness of breath with exercise.Transthoracic echocardiogram (tte) showed poor exercise capacity, no ischemia.However, blood pressure from 152/64 to 104/64 was noted with chest pain and shortness of breath.On the same day coronary angiography was performed for further evaluation which revealed 90% in-stent restenosis of the study stents in rca.On the same day, the patient was discharged and was planned for a coronary artery bypass graft (cabg).Eighteen days after, the patient presented for the scheduled cabg and was hospitalized.The patient underwent cabg from left radial artery to posterior left ventricular branch and posterior descending arteries.Additionally, skeletonized left internal mammary artery grafted to left anterior descending artery and skeletonized in-situ right internal mammary artery grafted to the obtuse marginal artery.In (b)(6) 2018, the event was considered as recovered and the patient was discharged.

• 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: 8628725
• Report Number: 2134265-2019-05429
• Device Sequence Number: 16636298
• Product Code: NIQ
• UDI-Device Identifier: 08714729840398
• UDI-Public: 08714729840398
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2018
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0021281229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/21/2019
• 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: Required Intervention
• Patient Age: 79 YR