MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA STENT 3.5 X 38; CARDIAC CORONARY DRUG-ELUTING STENT

Model Number 1550350-38

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/05/2021

Event Type  malfunction  

Event Description

Pt brought to operating room 5 for angiogram with stent placement.Coronary stent brought from cath lab.Stent aligned in patient but failed to deploy.Fda safety report id # (b)(4).

• Brand Name: XIENCE SIERRA STENT 3.5 X 38
• Type of Device: CARDIAC CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 11817269
• MDR Text Key: 250686583
• Report Number: MW5101318
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1550350-38
• Device Catalogue Number: 1550350-38
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR