MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1070300-48

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

Patient Problems Cardiac Arrest (1762); Ventricular Tachycardia (2132); Respiratory Failure (2484)

Event Date 06/18/2015

Event Type  Death  

Event Description

It was reported that the patient presented with st elevation myocardial infarction (stemi) and the procedure was to treat a chronic totally occluded, de novo lesion in the proximal left anterior descending (lad) artery with mild calcification.A 3.0 x 48 mm xience xpedition stent was implanted without any issues noted.The patient was compliant with dual antiplatelet drug therapy (dapt) and was fine post procedure.The next day, the patient suddenly developed ventricular tachycardia (vt) and intubation was done immediately followed by cardiopulmonary resuscitation (cpr); however, the patient experienced cardiac arrest and died.The cause of death reported was cardiac arrest.No additional information was provided.

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned.The reported patient effects of death and ventricular tachycardia, as listed in the xience xpedition everolimus eluting coronary stent system instructions for use (ifu) are known patient effects that may be associated with use of a coronary stent in native coronary arteries.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 issue with respect to manufacturing, design or labeling.The xience xpedition 48 is currently not commercially available in the u.S.However, it is similar to a device sold in the u.S.

• Brand Name: XIENCE XPEDITION 48 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: 4916695
• MDR Text Key: 6013078
• Report Number: 2024168-2015-03940
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/22/2015

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 Expiration Date: 01/24/2018
• Device Catalogue Number: 1070300-48
• Device Lot Number: 5011941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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
• Patient Outcome(s): Death