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

Catalog Number 1070350-18

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

Patient Problems Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 07/05/2021

Event Type  Death  

Manufacturer Narrative

The stent remains in the 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 procedure was to treat a mildly calcified lesion in the mildly tortuous left anterior descending (lad) artery.A 3.5x18mm xience xpedition drug eluting stent (des) was deployed in the proximal lad and a non-abbott stent was deployed in the mid-lad.Immediately after the implantation of both stents, thrombus formed at the proximal part of the lad.The thrombus then was noted to move to the left main and left circumflex (cx) arteries.The patient experienced cardiac arrest.Anti-thrombotic agents were given and cardiopulmonary resuscitation was performed, but the patient could not be revived and expired.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 thrombosis, embolism and death are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.The event was further reviewed by an abbott medical advisor who concluded that prior to the patient¿s death, anti-thrombotic medications and cardiopulmonary resuscitation were given to the patient.The physician felt that the patient did not expire due to the xience xpedition, but that heparin could be the reason; however, they did not elaborate on why they felt that heparin could be a cause of death.With the information received, it can be stated that the patient death was not caused by the xience xpedition, but rather was due to a procedural error.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It is the physician¿s opinion, the 3.5x18mm xience xpedition des is not suspected to be the cause of death, but heparin may have led to the patient expiration.

• Brand Name: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12229673
• MDR Text Key: 263590206
• Report Number: 2024168-2021-06513
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2023
• Device Catalogue Number: 1070350-18
• Device Lot Number: 004214A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MITIGATOR DES.; MITIGATOR DES
• Patient Outcome(s): Death