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

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

Patient Problems Angina (1710); Dyspnea (1816); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Nausea (1970); Weakness (2145)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Dates estimated.Udi#: in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record could not be performed as the lot number was not provided.The reported patient effects of angina, dyspnea, fatigue, hypersensitivity, hypertension and nausea are listed in the xience alpine everolimus eluting coronary stent system instructions for use as known patient effects.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 the design, manufacture, or labeling of the device.The additional xience alpine stent is being filed under a separate medwatch report.

Event Description

It was reported that two xience alpine stents were implanted on (b)(6) 2018.Ever since, the patient has experienced severe chest pain, nausea, fatigue, shortness of breath, weakness, high blood pressure and has returned to the emergency room (er) twice.No treatment was performed during the er visits.The patient is concerned that she is allergic to the drug coating on the stent.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: 7907573
• MDR Text Key: 121654820
• Report Number: 2024168-2018-07378
• Device Sequence Number: 1
• Product Code: NIQ
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2018
• 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: XIENCE ALPINE
• Patient Outcome(s): Hospitalization