MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number	H7493926028300
Health Effect - Clinical Codes	Chest Pain (1776); Myocardial Infarction (1969)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of coronary artery disease, status post transcatheter aortic valve replacement.To emergency department with chest pain, non-st-segment elevation myocardial infarction.While having a heart cath, balloon angioplasty, the stent opened but tip was observed to be damaged when trying to advance.The device was removed without know harm to the patient.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10689817
• Report Number: 10689817
• Device Sequence Number: 14267700
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: (01)08714729840299(17)211118(10)24833028
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/05/2020
• Report Date (Section F): 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493926028300
• Device Catalogue Number: H7493926028300
• Device Lot Number: 24833028
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/05/2020