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

Model Number	10600
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Used (b)(6) 2019 as event date as there was no date provided.
Event or Problem Description
It was reported that stent thrombosis occurred.A 3.5x8mm synergy ii drug eluting stent was deployed to treat the target lesion.However, two hours post-deployment, the patient developed chest pain and electrocardiography (ecg) was performed.Thrombosis within the previously implanted stent was noted.Percutaneous transluminal coronary angiography was performed and a non bsc heart pump was placed.No further patient complications were reported and the patient's status was stable.

• 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: 8331599
• Report Number: 2134265-2019-01036
• Device Sequence Number: 10801813
• Product Code: NIQ
• UDI-Device Identifier: 08714729840008
• UDI-Public: 08714729840008
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2020
• Device Model Number: 10600
• Device Catalogue Number: 10600
• Device Lot Number: 22795256
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/12/2019
• 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