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

Model Number	1550275-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	02/15/2020
Type of Reportable Event	Serious Injury
Additional 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 atrial arrhythmias/fibrillation is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, 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.
Event or Problem Description
It was reported that on (b)(6) 2020 the patient presented with a non-st elevated myocardial infarction (nstemi) therefore the 2.75x28mm xience alpine was implanted.On (b)(6) 2020 the patient was re-admitted due to atrial fibrillation, and other cardiovascular symptoms.It is unknown what treatment was performed and the final patient outcome is unknown.No additional information was provided.
Additional Manufacturer Narrative
Nab1- product problem removed.B5 - case details updated to reflect the complaint device was a xience sierra.
Event or Problem Description
It was reported that on (b)(6) 2020 the patient presented with non-st elevated myocardial infraction (nstemi) therefore the 2.75x28mm xience alpine was implanted.On (b)(6) 2020 the patient was re-admitted due to atrial fibrillation, and other cardiovascular symptoms.It is unknown what treatment was performed and the final patient outcome is unknown.Additional information was received and the correct device used in the procedure is a 2.75x28mm xience sierra stent.No additional information was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10169342
• Report Number: 2024168-2020-05144
• Device Sequence Number: 2143457
• Product Code: NIQ
• UDI-Device Identifier: 08717648227202
• UDI-Public: 08717648227202
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2020
• Device Model Number: 1550275-28
• Device Catalogue Number: 1550275-28
• Device Lot Number: 9032841
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 87