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

Model Number	1125350-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	06/01/2020
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 could not be conducted because the lot number was not provided.The reported patient effects of angina, thrombosis and myocardial infarction are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears 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.The additional xience alpine device is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a 50% stenosed, fibrous plaque, and mildly calcified de novo lesion in the proximal left anterior descending artery (lad) and a 75-90% stenosed, fibrous plaque, mildly tortuous, and mildly calcified de novo lesion in the mid lad.On (b)(6) 2015, a 3.5x15mm xience alpine stent was implanted in the proximal lad and 3.5x38mm xience alpine stent was implanted in the mid lad.The stents expanded to 3.5mm and were apposed to the vessel walls.On (b)(6) 2016, during a follow-up visit it was confirmed that there was no re-stenosis.On (b)(6) 2020, an exercise echocardiography was performed and confirmed ischemia in the lad was negative.On (b)(6) 2020, the patient stopped taking aspirin.On (b)(6) 2020, the patient had sudden chest pain and was taken to the hospital.V1-4 and clear st increase were shown and echo confirmed wall movement of the left ventricle anteroseptal.A st-elevation myocardial infarction was confirmed in the lad.An angiograph confirmed stent thrombosis in the 3.5x15mm xience alpine stent.A percutaneous coronary intervention was performed and large amounts of red thrombosis was suctioned out and a non-abbott stent was deployed.The mid lad was in a deeper position; therefore, thrombosis could not be clearly determined but larger amounts of thrombus was sucked from that part of the lesion.The patient recovered.No additional information was provided.

• 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: 10353820
• Report Number: 2024168-2020-06404
• Device Sequence Number: 19432666
• Product Code: NIQ
• UDI-Device Identifier: 08717648199523
• UDI-Public: 08717648199523
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2020

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: 1125350-15
• Device Catalogue Number: 1125350-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 07/31/2020
• 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: 66 YR
• Patient Weight: 87