MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE SIERRA¿; CORONARY DRUG-ELUTING STENT

Model Number	1550400-12
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: the date of procedure estimated as (b)(6) 2024.H6: medical device problem code 2017 - use after expiration.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported the 2.75x18mm rx xience sierra stent delivery system (sds) and the 4.0x12mm rx xience sierra sds both failed to cross the lesion.The procedure was completed using a non-abbott device.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.It was noted the 4.0x12 rx xience sierra was used past the expiration date.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information provided, a definitive cause for the reported issue could not be determined.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5 - describe event or problem: updated h6: code 2017 removed.
Event or Problem Description
Subsequent to the initially filed medwatch report, additional information was received.The device was not used past the expiration date.No additional information was provided.

• Brand Name: XIENCE SIERRA¿
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20450834
• Report Number: 2024168-2024-12128
• Device Sequence Number: 8616546
• Product Code: NIQ
• UDI-Device Identifier: 08717648227486
• UDI-Public: (01)08717648227486(17)250508(10)204304B
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2025
• Device Model Number: 1550400-12
• Device Catalogue Number: 1550400-12
• Device Lot Number: 204304B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown