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

Catalog Number	1125300-15
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Angina (1710)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.The reported patient effect of angina is listed in the xience alpine everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.Additionally, it should be noted that the ifu states: the xience alpine stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions.In addition, the xience alpine stent system is indicated for treating de novo chronic total coronary occlusions.In this case, the violation of the ifu does not appear to have contributed to the reported difficulties.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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 manufacture, design or labeling.The 3.0x18mm xience alpine is being filed under a separate medwatch mfr number.
Event or Problem Description
On (b)(6) 2017, a 3.0x18mm xience alpine stent was implanted.On (b)(6) 2018, the patient was re-admitted with stent restenosis.A 3.0x15mm xience alpine stent was deployed to treat the restenosis.On (b)(6) 2018, the patient was re-admitted with chest pain and other unspecified cardiovascular symptoms.Unspecified treatment was administered to the patient.Final patient outcome is reportedly unknown.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: 7866558
• Report Number: 2024168-2018-07086
• Device Sequence Number: 13956453
• Product Code: NIQ
• UDI-Device Identifier: 08717648199349
• UDI-Public: 08717648199349
• 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): 09/11/2018

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 Expiration Date: 03/19/2021
• Device Catalogue Number: 1125300-15
• Device Lot Number: 8030541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/11/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 82