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

Catalog Number 1125275-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Death (1802); Fatigue (1849); Thrombosis (2100); Vasoconstriction (2126)

Event Date 05/26/2018

Event Type  Death  

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 referenced is filed under a separate medwatch report.

Event 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
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7592639
• MDR Text Key: 110791109
• Report Number: 2024168-2018-04406
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199271
• UDI-Public: 08717648199271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 1125275-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STENT: 2.25X18MM XIENCE ALPINE
• Patient Outcome(s): Death