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

Catalog Number 1070350-23

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

Patient Problems Angina (1710); Bradycardia (1751); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Dizziness (2194)

Event Date 01/29/2015

Event Type  Injury  

Event Description

It was reported that the patient had chest discomfort after the xience xpedition stent was implanted in the proximal left anterior descending coronary artery.No treatment was given and the chest discomfort resolved the next day.The day after the procedure, the patient felt lightheaded when standing up.No treatment was given for this and the condition resolved the same day.Five days after the procedure, the patient was rehospitalized with ongoing, non-radiating retrosternal chest pain with lethargy, dyspnea, and dizziness when standing.The patient also had an elevated troponin (double the normal upper limit), hypotension and bradycardia.Medication was given and these conditions resolved the next day.There was no adverse patient sequela.Coronary angiogram was not performed.The study physician assessed the event as not related to the device but related to the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported device malfunction and the product was not returned.The reported patient effects of angina, bradycardia, hypotension, fatigue, enzyme elevation, and dyspnea, as listed in the xience xpedition everolimus eluting coronary stent system instructions for use, are known patient effects that may be associated with the use of coronary stents.A review of the lot history record revealed no non-conformances from this lot.Although 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 deficiency with respect to manufacturing, design or labeling.

• Brand Name: XIENCE XPEDITION 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 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4620598
• MDR Text Key: 5592512
• Report Number: 2024168-2015-01492
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2015
• Device Catalogue Number: 1070350-23
• Device Lot Number: 4071641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: ASPIRIN, TICAGRELOR
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 74