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

Catalog Number	1125350-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	07/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A 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 dyspnea is listed in the xience alpine everolimus eluting coronary stent system, instructions for use as a known patient effect.A conclusive cause for the reported patient effect, 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 of the device.The rx ultra device is being filed under a separate medwatch mfr number.
Event or Problem Description
It was reported that the index procedure took place on (b)(6) 2018 during which a 3.5 x 15 mm xience alpine stent and a 5.0 x 38 mm ultra multi-link stent were implanted for treatment of an unspecified vessel.The patient was readmitted to the hospital on (b)(6) 2018 for shortness of breath.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: 7870818
• Report Number: 2024168-2018-07127
• Device Sequence Number: 16535785
• Product Code: NIQ
• UDI-Device Identifier: 08717648199523
• UDI-Public: 08717648199523
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2018

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: 02/20/2021
• Device Catalogue Number: 1125350-15
• Device Lot Number: 8021241
• 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: 09/12/2018
• 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: 62 YR
• Patient Weight: 96