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

Model Number	10603
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: estimated based on aware date of (b)(6) 2020.
Event or Problem Description
It was reported that stent damage and shaft break occurred.The target lesion was located in a coronary artery.Following pre-dilatation with a 2.50 x 12 emerge balloon catheter, a 2.75 x 20 synergy ii drug-eluting stent was advanced but failed to cross the lesion.The device was removed and the stent struts were noted to be lifted at the proximal portion.Part of the delivery system broke off as well.There were no patient complications 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: 10762525
• Report Number: 2134265-2020-15056
• Device Sequence Number: 14268282
• Product Code: NIQ
• UDI-Device Identifier: 08714729840169
• UDI-Public: 08714729840169
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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: 01/03/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0023188736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1