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

Catalog Number 1070300-38

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

Patient Problems Cardiac Arrest (1762); Death (1802); Occlusion (1984); Respiratory Distress (2045)

Event Date 02/16/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).There was no reported device malfunction and the product was not returned.The reported patient effect of occlusion and death as listed in the xience xpedition everolimus eluting coronary stent systems instructions for use are known patient effects of coronary stenting procedures.Although a relationship between the reported patient effect and the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design, or labeling.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.

Event Description

It was reported that the procedure was to treat a de novo lesion located in the mildly calcified, mildly tortuous, distal left anterior descending artery.The patient had presented with chest pain and experiencing an anterior wall myocardial infarction.The patient had low blood pressure and was in cardiogenic shock.After thrombus aspiration was performed, the 3.0 x 38 mm xience xpedition was placed in the lesion and was confirmed to be fully apposed to the vessel wall.A no flow phenomenon was observed.The patient developed electro-mechanical dissociation and left ventricular failure.Cpr was performed for 30-45 minutes along with an adrenalin injection.Cardiac compression with a mechanical ventilator was delivered via endotracheal tube.Despite resuscitation attempts the patient could not be revived and was declared dead.An autopsy was not performed.The cause of death was cardiac arrest.No additional information was provided.

• 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 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; 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: 5478281
• MDR Text Key: 39626870
• Report Number: 2024168-2016-01341
• 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: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2018
• Device Catalogue Number: 1070300-38
• Device Lot Number: 5091541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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