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

Model Number	1125250-38
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received.Investigation is not yet done.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that after the stent system was prepared, it may not have been checked for damage prior to entering the patient anatomy.During the posterior tibial artery intervention, the stent delivery system was advanced to the lesion and the balloon inflated, but the stent was not on the balloon.The patient anatomy was checked, and no stent was present in the patient.The device was removed without issue.There was no adverse patient effect or a clinically significant delay in procedure.Another stent system was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.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 other incidents.It should be noted that the xience alpine, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu), states: the xience alpine stent system is indicated for improving coronary artery luminal diameter in patients, with symptomatic heart disease due to de novo native coronary artery lesions.It is unknown if the ifu deviation contributed to the reported event.It should also be noted, that the ifu, specifies: prior to using the xience alpine stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.It is unknown if the ifu deviation contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: XIENCE ALPINE 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: 11852779
• Report Number: 2024168-2021-04221
• Device Sequence Number: 3910999
• Product Code: NIQ
• UDI-Device Identifier: 08717648199219
• UDI-Public: 08717648199219
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 06/08/2021

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: 09/10/2022
• Device Model Number: 1125250-38
• Device Catalogue Number: 1125250-38
• Device Lot Number: 9090541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 101