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	H7493926032400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969)
Date of Event	01/13/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is 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#2134265-2018-01625, 2134265-2018-01626, 2134265-2018-01627, and 2134265-2018-01628.It was reported that st elevation myocardial infarction (stemi) and death occurred.A 4.00mmx32mm synergy stent was advanced but was unable to cross the target lesion.At some time during the procedure three emerge balloons, a 2.00x20mm, a 3.0x20mm, and a 3.0x30mm, were used along with a 3.5x15mm nc quantum balloon.The patient was reported to have experienced stemi and subsequently died.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Also same case as mdr# 2134265-2018-02211.Previously it was reported that st elevation myocardial infarction (stemi) occurred during the procedure but now it is reported the patient presented with stemi.It was further reported that the 100% stenosed target lesion was located in a severely calcified, non-tortuous, mid to distal right coronary artery (rca).The 3.0x20mm emerge balloon was used first, followed by the 3.0x30mm and 2.0x20mm emerge balloons, and the 3.5x15mm nc quantum balloon.Prior to the patient's death, angioplasty, thrombectomy, and stenting with a 3.5 x 32 synergy ii stent were performed.The patient died due to cardiac arrest.The physician did not consider the patient's death to be related to these devices.

• 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: 7278279
• Report Number: 2134265-2018-00872
• Device Sequence Number: 19408315
• Product Code: NIQ
• UDI-Device Identifier: 08714729840374
• UDI-Public: 08714729840374
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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: 06/29/2018
• Device Model Number: H7493926032400
• Device Catalogue Number: 39260-3240
• Device Lot Number: 20850365
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 03/09/2018
• 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: Death