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

Lot Number 0091641

Device Problems Separation Failure (2547); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2020

Event Type  Injury  

Event Description

Md placing xience sierra drug eluting stent, when device withdrawn, stent still attached to the device and not inside the artery.Once removed, the stent fell off of the balloon.Fda safety report id# (b)(4).

• Brand Name: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS CORONARY DRUG ELUTING STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR ; santa clara CA 95054
• MDR Report Key: 11131374
• MDR Text Key: 225779209
• Report Number: MW5098703
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2022
• Device Lot Number: 0091641
• 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?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 107