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

Model Number	1125350-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in the patient.Review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of stenosis is listed in the xience alpine, everolimus eluting coronary stent system (eecss), instructions for use as a known patient effect 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 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 of the device.
Event or Problem Description
It was reported that on (b)(6) 2017, the patient presented with myocardial infarction.The procedure was to treat a thrombosed lesion in the right coronary artery.A 3.5x18mm xience alpine stent was implanted using low pressure dilatation, preventing distal embolic plaque from going further.On (b)(6) 2018, during a follow-up consultation, an intravascular ultrasound was performed and 50% stenosis was confirmed but no treatment conducted, and it was determined to be under observation.The physician explained there was no product problem.No additional information was provided.

• Brand Name: XIENCE ALPINE
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9886172
• Report Number: 2024168-2020-02994
• Device Sequence Number: 2804142
• Product Code: NIQ
• UDI-Device Identifier: 08717648199530
• UDI-Public: 08717648199530
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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: 02/12/2020
• Device Model Number: 1125350-18
• Device Catalogue Number: 1125350-18
• Device Lot Number: 7020241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/26/2020
• 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