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

Model Number	1125275-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.It should be noted that the reported patient effects of angina and stenosis are listed in the xience alpine, everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the reported treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2018, the patient presented with angina, and a severely calcified, 95% stenosed lesion within the proximal left anterior descending (lad) coronary artery.Pre-dilatation and an atherectomy was performed.A 2.75x15mm xience alpine stent (1125275-15) was implanted with acceptable results, timi flow iii and 0% visual diameter stenosis.On (b)(6) 2019, the patient was admitted for chest pain.Per recent catheritization, the patient had triple vessel coronary artery disease.As treatment, a coronary artery bypass graft x4 procedure was performed.Post-operation day 1, atrial fibrillation/flutter was observed and the patient presented with an altered mental status.The patient went into respiratory failure and was re-intubated.Cardioversion was provided for the arrhythmias.Medications were provided for hypotension.Neurology was consulted.The ct scan was negative and the patients mental status improved off sedation.Post-op day 5, the patient was extubated and was observed in sinus rhythm.The patient was started on medications for atrial fibrillation.Post-operation day 12, the patient was discharged to a subacute rehab facility.The events had resolved.There was no device malfunction.No additional information was provided regarding this issue.

• 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: 10310971
• Report Number: 2024168-2020-06121
• Device Sequence Number: 3398838
• Product Code: NIQ
• UDI-Device Identifier: 08717648199257
• UDI-Public: 08717648199257
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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 Model Number: 1125275-15
• Device Catalogue Number: 1125275-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/22/2020
• 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; Disability
• Patient Age: 69 YR
• Patient Weight: 100