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

Catalog Number	1550250-08
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code 2017 - use after expiration.The stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.H3 other text : the stent remains in patient.
Event or Problem Description
It was reported that the procedure was to treat a diagonal artery.A 2.50x08mm xience sierra stent was implanted at the lesion.It was only after the implantation did the physician realize that the stent implant had expired on (b)(6) 2019.The patient is fine.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.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.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 the design, manufacture or labeling of the device.

• 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: 8885620
• Report Number: 2024168-2019-10781
• Device Sequence Number: 11445835
• Product Code: NIQ
• UDI-Device Identifier: 08717648227073
• UDI-Public: 08717648227073
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 06/27/2019
• Device Catalogue Number: 1550250-08
• Device Lot Number: 8061941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1