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

Model Number	10601
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that a stent damage occurred.The target lesion was located in the left anterior descending artery.After a non-bsc guide extension catheter was advanced, a 3.50x12mm synergy ii drug-eluting stent (des) was advanced for treatment.However, resistance was met at the collar of the guide extension catheter and it kinked the shaft of the stent outside the patient's body.Another 3.50x12mm synergy ii des was advanced through the guide to the collar of the guide extension catheter however, it was noted that the proximal end of the stent struts were raised.The device was removed with the guide extension catheter and used a 3x16mm synergy des and completed the procedure.No patient complications were reported.

• 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: 8462753
• Report Number: 2134265-2019-03177
• Device Sequence Number: 2746358
• Product Code: NIQ
• UDI-Device Identifier: 08714729840060
• UDI-Public: 08714729840060
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2020
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0023082409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1