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

Catalog Number 1074250-08

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

Patient Problems Aneurysm (1708); Fever (1858); Unspecified Infection (1930); Myocardial Infarction (1969)

Event Date 09/21/2014

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014, the patient presented to the hospital with an acute myocardial infarction (ami).The 2.5x08mm xience xpedition and 2.5x23mm xience xpedition stent implants were successfully deployed to treat a lesion in the proximal left anterior descending (lad) artery.Intravascular ultrasound (ivus) confirmed full apposition of the stent implants.There were no device issues or procedure issues noted and the procedure was completed successfully.The patient was discharged with regular dual antiplatelet therapy (dapt) medication.On (b)(6) 2014, the patient presented to the hospital with a fever and subsequently experienced an st segment elevation myocardial infarction (stemi).Angiogram revealed an aneurysm in the lad stented area.The aneurysm was leaking pus into the pericardium.A biopsy of the aneurysm revealed salmonella.Reportedly, the patient has a history of colitis and sepsis, which were being treated with medication (remicade and prednisone).Coronary artery bypass grafting (cabg) was performed the same day and the patient was discharged on (b)(4) 2014.There was no additional information provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A similar incident query in the complaint handling database for this lot was not performed as the lot history record revealed no non-conformances that would have contributed to the reported event.Aneurysm, fever, infection, and myocardial infarction are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.Based on the information reviewed, there is no evidence to indicate the presence of a product deficiency.The 2.5x23mm xience xpedition device referenced, is being filed under a separate medwatch mfr number.

• 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: 4175601
• MDR Text Key: 5021977
• Report Number: 2024168-2014-06721
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2015
• Device Catalogue Number: 1074250-08
• Device Lot Number: 3071741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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: 2.5X23MM XIENCE XPEDITION
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 65 YR