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

Model Number	1125275-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Atrial Fibrillation (1729); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Ischemia (1942); Heart Failure (2206); Test Result (2695)
Date of Event	11/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
Patient id: (b)(6).It was reported that a percutaneous coronary intervention was performed on (b)(6) 2019.A 2.75x18mm xience alpine stent was implanted in the proximal-mid left anterior descending (lad) coronary artery lesion and a 2.5x12mm xience alpine stent was implanted in the mid lad.The procedure was performed without complications.Starting on (b)(6) 2019, the patient experienced acute on chronic heart failure.The patient was admitted to the hospital with dyspnea, orthopnea, and angina.Elevated troponin and the ejection fraction was observed at 50-55%.Reportedly, the elevated troponin was related to demand ischemia secondary to heart failure and atrial fibrillation.Medications were provided.On (b)(6) 2019, a non-abbott stent was implanted in the stenosed proximal lad, more proximal and slightly overlapping the previously implanted mid-proximal lad 2.75x18mm xience alpine stent.Medications were also provided.Per physician, the events were unrelated to the xience alpine stents and unrelated to the index procedure.There was no device malfunction.The event resolved without sequela.There was no additional information provided regarding this issue.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the reported patient effect(s) of angina, ischemia and atrial fibrillation are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 9935627
• Report Number: 2024168-2020-03476
• Device Sequence Number: 14132562
• Product Code: NIQ
• UDI-Device Identifier: 08717648199264
• UDI-Public: 08717648199264
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• 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: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2020
• Device Model Number: 1125275-18
• Device Catalogue Number: 1125275-18
• Device Lot Number: 7041761
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 79