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	H7493926012270
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Chest Pain (1776); Thrombosis (2100)
Date of Event	01/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-00981 and 2134265-2018-00876.It was reported that stent thrombosis and chest pain occurred.The patient presented with an acute st elevated myocardial infarction and received bivalirudin therapy (blood thinner).Target lesion #1 was located in the circumflex artery.Following predilation using a 2.50 mm x 20 mm emerge balloon, a 2.50 x 24 mm synergy ii stent was successfully deployed.Target lesion #2 was located in the left anterior descending (lad) artery.Predilation was performed with a 2.50 mm x 15 mm emerge balloon.A 2.75 x 12 mm synergy ii stent system deployed in the lad and a 2.75 x 20 mm synergy ii everolimus stent was deployed in the distal lad.The procedure was completed and the patient was then transferred from cath lab however, the patient started having chest pain.The patient was brought back to the cath lab and it was noted that a focal clot was present in both the mid circumflex and mid lad.A 2.50 mm x 15 mm emerge balloon was used to dilate the clot present inside the synergy stents.No further patient complications were reported and the patient's status was fine.The patient was discharged from the hospital four days later.

• 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: 7268012
• Report Number: 2134265-2018-00947
• Device Sequence Number: 1372621
• Product Code: NIQ
• UDI-Device Identifier: 08714729840046
• UDI-Public: 08714729840046
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/19/2018

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: 05/23/2018
• Device Model Number: H7493926012270
• Device Catalogue Number: 39260-1227
• Device Lot Number: 0020705090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/13/2018
• 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