MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA; CORONARY DRUG-ELUTING STENT

Model Number 2.25MM X 15MM

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 05/08/2019

Event Type  malfunction  

Event Description

Balloon broke off from the end of the catheter after stent deployment.Fda safety report id # (b)(4).

• Brand Name: XIENCE SIERRA
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 8611950
• MDR Text Key: 145280139
• Report Number: MW5086632
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2020
• Device Model Number: 2.25MM X 15MM
• Device Catalogue Number: 1550225-15
• Device Lot Number: 9021341
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: No Information
• 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: 71 YR
• Patient Weight: 35