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

Model Number H7493926028300

Device Problems Unraveled Material (1664); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

Event 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
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11640618
• MDR Text Key: 244618581
• Report Number: 11640618
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: (01)08714729840299(17)221116(10)26404846
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: H7493926028300
• Device Catalogue Number: H7493926028300
• Device Lot Number: 26404846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 110