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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
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.
 
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Brand NameXIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG 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 Key11339844
MDR Text Key232261195
Report Number2024168-2021-01266
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeAS
PMA/PMN Number
P110019
Number of Events Reported1
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 Received02/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/12/2022
Device Catalogue Number1500225-08
Device Lot Number9050341
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 Received03/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2019
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
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