MAUDE Adverse Event Report: ABBOTT VASCULAR RX SIERRA; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number 1550350-33

Device Problem Expiration Date Error (2528)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that a 3.5x33mm xience sierra stent delivery system was labeled with a shelf life of three years when it should have been labeled with a shelf life of one year.The device was not used and there was no patient involvement.No additional information was provided.

Manufacturer Narrative

On march 19, 2020, abbott vascular determined that a field safety corrective action is required regarding one lot of the xience sierra rx everolimus eluting coronary stent system.Devices from this lot were shipped with a 36-month labeled expiration date instead of the 12-month expiration date that is currently approved in the united states.The label indicates an expiration date of march 21, 2022, while the fda approved expiration date is march 31, 2020.This action does not affect patients having successfully undergone procedures using these devices.The customer reported the device is retained by hospital and not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.H7 - if remedial action initiated updated from "none selected" to "notification".

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified the nonconformity issued to the reported lot identifying the reported issue of expiration date error addressed in this investigation.A review of the complaint history identified no other incidents from this lot.The investigation determined the reported expiration date error appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

• Brand Name: RX SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9856203
• MDR Text Key: 184179463
• Report Number: 2024168-2020-02654
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227455
• UDI-Public: 08717648227455
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 1550350-33
• Device Catalogue Number: 1550350-33
• Device Lot Number: 903224A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1