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

Model Number	1550350-28
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4), use after expiration.The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.The additional xience sierra device referenced is filed under a separate medwatch report number.Na.
Event or Problem Description
It was reported that two expired xience sierra stents were implanted.There was no adverse patient effect and no clinically significant delay in the procedure.The patient was stable.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.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 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
• MDR Report Key: 10197629
• Report Number: 2024168-2020-05345
• Device Sequence Number: 11403400
• Product Code: NIQ
• UDI-Device Identifier: 08717648227448
• UDI-Public: 08717648227448
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 08/13/2020

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: 04/16/2020
• Device Model Number: 1550350-28
• Device Catalogue Number: 1550350-28
• Device Lot Number: 9041041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XIENCE SIERRA STENT IMPLANT