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

Catalog Number 1500225-08

Device Problem Failure to Advance (2524)

Patient Problems Cardiac Arrest (1762); Tachycardia (2095); Prolapse (2475)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Reportedly, the device is not returning for analysis. Investigation is not complete. A follow-up report will be submitted with all additional relevant information. The additional xience sierra device referenced in b5 is filed under a separate medwatch report number.

Event Description

It was reported that on (b)(6) 2020, a percutaneous coronary intervention (pci) was performed on multiple calcified lesions within the left anterior descending (lad) coronary artery. Pre-dilatation was performed. Following, both a 2. 5x12mm (1500250-12, 9060441) and 2. 25x8mm (1500225-08, 9050341) xience sierra stent delivery systems failed to cross the lesion mid-distal lad. Reportedly, the patient had calcified lesions throughout the lad. It was decided to abort the procedure. The patient was transferred to the critical care unit for monitoring. Shortly after arrival, the patient went into ventricular tachycardia, cardiac arrest, and was sent for emergency coronary artery bypass graft (cabg) placement. Reportedly, it was possible that some microvascular tissue or plaque disruption occurred due to the failure to crosses. The exact cause of the event was uncertain. No additional information was provided regarding this issue.

• 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 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11339844
• MDR Text Key: 232261195
• Report Number: 2024168-2021-01266
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/12/2022
• Device Catalogue Number: 1500225-08
• Device Lot Number: 9050341
• 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: 03/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• 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: 02/17/2021 Patient Sequence Number: 1