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

Model Number	10601
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Chest Pain (1776); Thrombosis (2100)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent partial deployment, sub- acute thrombosis and chest pain occurred.The target lesion was located in the significantly calcified left anterior descending (lad) artery.The lesion was treated with placement of 3.00x24mm, 3.00x38mm and 3.50x12mm synergy ii drug-eluting stents which were post dilated.Three days later, the patient had sub-acute thrombosis in the lad which needed to be expanded in the mid lad.The following day, the patient experienced chest pain.Intravascular ultrasound (ivus) revealed that the stents were under deployed.The lad was lasered and a quantum balloon was introduced to dilate the stents.Ivus revealed the stents had appropriate apposition and expansion.No further patient complications were reported and the patient's status was fine.

• 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: 9336418
• Report Number: 2134265-2019-13890
• Device Sequence Number: 19295256
• Product Code: NIQ
• UDI-Device Identifier: 08714729840060
• UDI-Public: 08714729840060
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2019

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 Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0023678029
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/18/2019
• 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: 61 YR