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

Model Number	10605
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of aware date as there was no date provided.Device is a combination product.
Event or Problem Description
It was reported that stent fracture occurred.The target lesion was located in a coronary artery.A 2.25x28mm synergy ii drug eluting stent was advanced to treat the lesion.However, the stent was fractured upon entering the artery.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient 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: 9879498
• Report Number: 2134265-2020-03472
• Device Sequence Number: 16998874
• Product Code: NIQ
• UDI-Device Identifier: 08714729840268
• UDI-Public: 08714729840268
• Combination Product (Y/N): N
• Initial Reporter Country: RQ
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2020

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: 06/10/2021
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0023956644
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1