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

Model Number	H7493926028300
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A (b)(6) years old patient with a history of hypertension, diabetes mellitus, a new onset of chest pain underwent a diagnostic cardiac catheterization.During the procedure, the boston scientific everolimus-eluting platinum chromium coronary stent system impacted a calcium buildup, prompting its retrieval from the patient.When attempting to reintroduce the everolimus-eluting platinum chromium coronary stent, the health care providers noticed that the device unraveled distally on the balloon with a fragment of the metal tubular mesh protruding from the device itself.Subsequently, a new device was used with no 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: 11640618
• Report Number: 11640618
• Device Sequence Number: 3100062
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: (01)08714729840299(17)221116(10)26404846
• 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): 03/31/2021
• Report Date (Section F): 03/31/2021

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: No Information
• Device Model Number: H7493926028300
• Device Catalogue Number: H7493926028300
• Device Lot Number: 26404846
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2021
• Patient Sequence Number: 1
• Patient Weight: 110
• Date Report Sent to FDA: 03/31/2021