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

Model Number 1550275-15

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

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

Event Date 11/11/2019

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 non-st elevated myocardial infarction (nstemi) therefore the 2.75x15mm xience sierra was implanted.On (b)(6) 2019 and (b)(6) 2019 the patient was re-admitted with other cardiovascular symptoms including atherosclerotic heart disease.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.

• 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: 9788004
• MDR Text Key: 183121944
• Report Number: 2024168-2020-02004
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227172
• UDI-Public: 08717648227172
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2019
• Device Model Number: 1550275-15
• Device Catalogue Number: 1550275-15
• Device Lot Number: 8102442
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 70