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

Model Number H7493926016300

Device Problem Structural Problem (2506)

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

Event Date 03/31/2021

Event Type  malfunction  

Event 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
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11633400
• MDR Text Key: 244400081
• Report Number: 11633400
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840114
• UDI-Public: (01)08714729840114(17)H7493926016300(10)26345897
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493926016300
• Device Catalogue Number: H7493926016300
• Device Lot Number: 26345897
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Weight: 65