MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1125225-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	09/02/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).The incident information was reviewed; however, there was no reported device malfunction and the product was not returned as the stent remains in the anatomy.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.The reported patient effects of death and myocardial infarction are listed in the xience alpine everolimus eluting coronary stent system instructions for use as known patient effects.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that a 2.25x28mm xience alpine stent was implanted on (b)(6) 2018.On (b)(6) 2018 the patient was re-admitted for acute myocardial infarction, non-st-elevation myocardial infarction and other unspecified cardiovascular symptoms.Unspecified treatment was administered to the patient.The final patient outcome has been reported as death due to major complications and comorbidities.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8170025
• Report Number: 2024168-2018-09756
• Device Sequence Number: 11189108
• Product Code: NIQ
• UDI-Device Identifier: 08717648199103
• UDI-Public: 08717648199103
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,other
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

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 Catalogue Number: 1125225-28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/17/2018
• 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: Death
• Patient Age: 86 YR
• Patient Weight: 83