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	H7493926016220
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Chest Pain (1776); Nausea (1970); ST Segment Elevation (2059); Thrombosis (2100)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-07227 and 2134265-2018-07229.It was reported that patient experienced chest pain and acute thrombosis occurred.The target lesion was located in the proximal to mid left anterior descending artery (lad).A 2.75x12 synergy ii drug-eluting stent was implanted in the proximal lad.The mid lad was treated with 2.25 x 16mm and a 2.25 x 12mm synergy ii drug-eluting stents.The final angiogram looked great.While the patient was being removed from the table, the patient experienced nausea and chest pain.The physician had ordered the patient to be loaded with aspirin and plavix but the patient refused to take any medication.Some time later, the patient did receive aspirin and plavix.The patient continued to have chest pain and some st elevation.An echo was performed which came back clear but the patient started to show more prominent st elevation.Another angiogram was performed which revealed the stented area had stent thrombosis.The patient was loaded with an integrilin bolus and started on an integrilin drip.A second integrilin bolus was given directly ic and the stented area dilated with a 2.0x12 balloon.The patient's st elevation disappeared, the patient had no chest pain, and the thrombosis was considered resolved.An intravascular ultrasound was performed which revealed the stents were well apposed.

• 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: 7753521
• Report Number: 2134265-2018-07228
• Device Sequence Number: 11192517
• Product Code: NIQ
• UDI-Device Identifier: 08714729840084
• UDI-Public: 08714729840084
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/17/2018

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: 03/20/2019
• Device Model Number: H7493926016220
• Device Catalogue Number: 39260-1622
• Device Lot Number: 0021950011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/06/2018
• 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: 87 YR