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

Model Number	1550225-28
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 did not indicate a lot specific quality issue.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 27-may-2020 with an expiration date (use by date) of 26-may-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 (ifu) 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 even.The investigation determined the reported difficulties appear to be related to circumstances of the procedure; however, 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.
Event or Problem Description
It was reported the procedure was to treat a lesion in the right coronary artery.The 2.25x28 mm xience sierra stent delivery system (sds) failed to cross the target lesion due to the anatomy.When retracting the sds, resistance was felt with the guide wire and the guide catheter and the stent struts flared.All devices were removed together as a single device.Additionally, it was noted that the 2.25x28 sierra was used past expiration.A new same size sierra crossed without further issues and was implanted.There were no adverse patient effects and no clinically significant delay in 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: 12508549
• Report Number: 2024168-2021-08393
• Device Sequence Number: 5338243
• Product Code: NIQ
• UDI-Device Identifier: 08717648227042
• UDI-Public: 08717648227042
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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: 05/26/2021
• Device Model Number: 1550225-28
• Device Catalogue Number: 1550225-28
• Device Lot Number: 0052141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR