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

Model Number 1550300-23

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Obstruction/Occlusion (2422); Prolapse (2475); Thrombosis/Thrombus (4440)

Event Date 05/27/2021

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 performed to treat a in-stent restenosis in the left anterior descending (lad). A 3. 0 x 23 mm xience sierra stent delivery system (sds) was advanced to the target lesion and the stent was implanted. However, it was noted that plaque shift had occurred which caused an obstruction to the septal and diagonal branches. The physician was able to use a guide wire to open up the branches. The procedure was completed. When the patient was taken off the table, the patient coded (cardiopulmonary arrest). The patient was put back on the table and stent thrombosis was noted. Aspiration was performed to treat the thrombus. A 4. 0 x 23 mm xience sierra stent was implanted in lad to the left main artery. The patient was taken to the recovery room and died shortly after. The patient had a history of not being compliant with the dual antiplatelet drug therapy (dapt). No additional information was provided.

• Brand Name: XIENCE SIERRA 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P031); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12017318
• MDR Text Key: 256736167
• Report Number: 2024168-2021-05082
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1550300-23
• Device Catalogue Number: 1550300-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/17/2021 Patient Sequence Number: 1