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

Model Number	H7493926016300
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of hypertension, anemia and new onset of chest pain and shortness of breath.Had procedure percutaneous intervention in heart cath lab.When the device was removed, it was observed that there is a build-up of coating on the stent delivery system.This did not impact use of product.The stent was successfully deployed.Had this build up been further up the delivery system, it would not have fit in the guide catheter.No known 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: 11633400
• Report Number: 11633400
• Device Sequence Number: 14367001
• Product Code: NIQ
• UDI-Device Identifier: 08714729840114
• UDI-Public: (01)08714729840114(17)H7493926016300(10)26345897
• 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): 04/06/2021
• Report Date (Section F): 04/06/2021

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 Model Number: H7493926016300
• Device Catalogue Number: H7493926016300
• Device Lot Number: 26345897
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 65
• Date Report Sent to FDA: 04/06/2021