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

Catalog Number	1125225-18
Health Effect - Clinical Codes	Arrhythmia (1721); Death (1802); Fatigue (1849); Thrombosis (2100); Vasoconstriction (2126)
Date of Event	05/26/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.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 arrhythmia, death, fatigue and thrombosis are listed in the xience alpine, everolimus eluting coronary stent system 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.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The other xience alpine stent is filed under a separate medwatch report.
Event or Problem Description
It was reported that the patient was admitted with st elevation myocardial infarction (mi).The coronary procedure was performed to treat a lesion in the left anterior descending artery.Nitroglycerin was administered due to vessel spasm.Pre-dilatation was performed at the target lesion.A 2.25 x 18 mm xience alpine stent was implanted first in the distal portion of the lesion and a 2.75 x 23 mm xience alpine was then implanted in the proximal to mid portion of the lesion.Nitroglycerin was administered due to continued vessel spasm.Post-dilatation was performed and the stents were well apposed to the vessel wall.Good blood flow was noted.One day post-procedure, the patient was pending discharge, but did not feel well.A pause was noted on telemetry.Cardiopulmonary resuscitation was started and the patient was transferred to the cath lab.Thrombus was noted within the entire stented portion of the lad.Despite resuscitation attempts, the patient died on (b)(6) 2018.There were no adverse patient effects and no clinically significant delay in the procedure.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: 7592585
• Report Number: 2024168-2018-04405
• Device Sequence Number: 1698888
• Product Code: NIQ
• UDI-Device Identifier: 08717648199080
• UDI-Public: 08717648199080
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2018

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 Catalogue Number: 1125225-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: 2.75X23MM XIENCE ALPINE
• Outcome Attributed to Adverse Event: Death