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

Model Number	10601
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft fracture and stent damage occurred.A 2.25 x 12mm synergy drug-eluting stent was advanced for treatment in a side branch of a coronary vessel.After an unsuccessful attempt to deliver the stent, the catheter shaft fractured 7 to 8 inches from the hub during removal.The fractured portion of the device was pulled out with the undeployed damaged stent still attached.The procedure was completed and there were no patient complications nor injuries 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: 10597916
• Report Number: 2134265-2020-12702
• Device Sequence Number: 3258558
• Product Code: NIQ
• UDI-Device Identifier: 08714729840022
• UDI-Public: 08714729840022
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/28/2020

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: 03/27/2021
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0023648957
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1