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

Model Number	10603
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The patient underwent percutaneous coronary artery (pci).Following pre-dilatation of a 2.5x10mm and 2.5x6mm non-bsc balloon catheters, a 3.50 x 20 synergy ii drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion and the stent was damaged during delivery.The device was removed.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: 11926509
• Report Number: 2134265-2021-07173
• Device Sequence Number: 4381135
• Product Code: NIQ
• UDI-Device Identifier: 08714729840183
• UDI-Public: 08714729840183
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: 12/02/2022
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0026510426
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1