MAUDE Adverse Event Report: BOSTON SCIENTIFIC PROMUS DES STENT 2.25 X 20

Model Number 39528-2022

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2016

Event Type  malfunction  

Event Description

Pt brought emergently to lab.When performing pci, the existing stent displaced after cutting balloon procedure was performed.This involved a promus stent with initial implant on (b)(6) 2016.Since this involves a company-wide contract by our parent company, catholic health initiatives, we are also informing our cardiac service line of this occurrence.

• Brand Name: PROMUS DES STENT 2.25 X 20
• Type of Device: STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5832725
• MDR Text Key: 50959138
• Report Number: MW5063714
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: 39528-2022
• Device Lot Number: 18704346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 127