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

Model Number	1550300-12
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	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis as it remains implanted in the patient.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 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 16-january-2020 with an expiration date (use by date) of 15-january-2021.The product was used after expiration as it was reported the procedure occurred on (b)(6) 2021.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.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.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified and tortuous right coronary artery.Prior to implanting the xience sierra stent, it was noted that the stent was expired.The stent was implanted without issue.There was no adverse patient effect and no clinically significant delay in the procedure.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
• MDR Report Key: 11362835
• Report Number: 2024168-2021-01368
• Device Sequence Number: 11606001
• Product Code: NIQ
• UDI-Device Identifier: 08717648227240
• UDI-Public: 08717648227240
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2021

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: 01/15/2021
• Device Model Number: 1550300-12
• Device Catalogue Number: 1550300-12
• Device Lot Number: 0010841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR