MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EVEROLIMUS ELUTING PLATINUM CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Catalog Number H7493941820400

Event Date 10/21/2021

Event Type  malfunction  

Event Description

When attempting to deploy the stent; the stent came off the deployment system.Fda safety report id # (b)(4).

• Brand Name: EVEROLIMUS ELUTING PLATINUM CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 13087447
• MDR Text Key: 282899216
• Report Number: MW5106266
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H7493941820400
• Device Lot Number: 27239183
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No