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

Model Number	H7493926020350
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of chronic heart failure and colon resection.While having a diagnostic heart cath, the stent was deployed but the balloon would not go back over the wire.Device removed without known harm to 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: 10867557
• Report Number: 10867557
• Device Sequence Number: 3285201
• Product Code: NIQ
• UDI-Device Identifier: 08714729840183
• UDI-Public: (01)08714729840183(17)220713(10)25751232
• 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): 11/17/2020
• Report Date (Section F): 11/17/2020

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 Model Number: H7493926020350
• Device Catalogue Number: H7493926020350
• Device Lot Number: 25751232
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2020
• Patient Sequence Number: 1
• Patient Weight: 58
• Date Report Sent to FDA: 11/17/2020