MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070300-28

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

Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 01/29/2020

Event Type  Death  

Manufacturer Narrative

The stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the patient presented with a st-elevation myocardial infarction (stemi).Pre-dilatation of the lesion was performed with a 2.5x12 mm traveler balloon dilatation catheter (bdc).After preparation of the lesion, the patient experienced ventricular tachycardia (vt) and it was stabilized within a few seconds.It was confirmed that the traveler bdc was not associated and there were no other issues with the bdc.The lesion was then stented with a 3.0x28 mm xience xpedition stent.Post procedure, the patient was transferred to the intensive care unit (icu) and was stable.After 3 hours the patient experienced vt and ventricular fibrillation (vf) and then cardiac arrest.Cpr was performed; however, the patient expired.There were no issues with the traveler bdc and there were no issues with deployment of the xience xpedition stent.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of death/expired, ventricular fibrillation and ventricular tachycardia are listed in the xience xpedition, everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.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 manufacture, design or labeling.

• Brand Name: XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9746618
• MDR Text Key: 180626281
• Report Number: 2024168-2020-01726
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Catalogue Number: 1070300-28
• Device Lot Number: 9062141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death