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

Catalog Number	1550400-33
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 4.0x33mm xience sierra expired stent was implanted.There were no issues with the stent or deployment.There was no adverse patient effects reported and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code: 2017 clarifier: use after expiration.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for evaluation.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history was not performed because the failure mode was not specified.It was reported that the xience sierra was used past the expiration date.A review of the xience sierra label attached to the lot history record for this lot was conducted indicating a manufacturing date of 10-march-2021 with an expiration date (use by date) of 09-march-2024.The product was used after expiration as it was reported the procedure occurred on (b)(6) 2024.The expiration date of the product is important for sterility, efficacy, and performance of the device.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) states: note the product use by (expiration) date specified on the package.It is likely the ifu deviation of device expiration issue contributed to the event; however, no in-service letter will be requested as the case information noted that the user is already aware of the deviation.The investigation determined the reported device expiration issue appears to be related to the use error.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Corrections: section e.Initial reporter updated to: dr.(b)(6) (physician).G2 - report source "other" was removed; g2 - other report source "cath lab director" was removed and replaced with "na".
Event or Problem Description
Subsequently, after the initial was filed it was noted that the stent was implanted in the mid right coronary artery.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 19061029
• Report Number: 2024168-2024-04396
• Device Sequence Number: 20507096
• Product Code: NIQ
• UDI-Device Identifier: 08717648227530
• UDI-Public: (01)08717648227530(17)240309(10)103034A
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 03/09/2024
• Device Catalogue Number: 1550400-33
• Device Lot Number: 103034A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2021
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White