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

Model Number	10607
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	07/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combation product.
Event or Problem Description
It was reported that the patient experienced chest pain.A 3.00 x 38mm synergy drug eluting stent was advanced for treatment.However, the device failed to cross the lesion and the patient continue to have chest pain.

• 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: 10414399
• Report Number: 2134265-2020-10215
• Device Sequence Number: 16746672
• Product Code: NIQ
• UDI-Device Identifier: 08714729840411
• UDI-Public: 08714729840411
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

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 Expiration Date: 11/03/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024739159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/17/2020
• 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: Other