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

Model Number 1550225-28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); No Code Available (3191)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of stenosis is listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that on (b)(6) 2019 the patient presented with unstable angina therefore the 2.25x28mm and 2.50x33mm xience sierra stents were implanted.On (b)(6) 2019 the patient was re-admitted with atherosclerotic heart disease and other cardiovascular symptoms.It is unknown what treatment was performed and the final patient outcome is unknown.No additional information was provided.

Manufacturer Narrative

Patient code 2263 was removed.Conclusion code 22 was removed.

Event Description

It was reported that on (b)(6) 2019 the patient presented with unstable angina therefore the 2.25x28mm and 2.50x33mm xience sierra stents were implanted.On (b)(6) 2019 the patient was re-admitted with atherosclerotic heart disease and other cardiovascular symptoms.It is unknown what treatment was performed and the final patient outcome is unknown.No additional information was provided.

• Brand Name: XIENCE 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: 9788173
• MDR Text Key: 182143160
• Report Number: 2024168-2020-02009
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227042
• UDI-Public: 08717648227042
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2020
• Device Model Number: 1550225-28
• Device Catalogue Number: 1550225-28
• Device Lot Number: 9021341
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2.50X33 XIENCE SIERRA.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 118