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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
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.
 
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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 (P031)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key12017318
MDR Text Key256736167
Report Number2024168-2021-05082
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648227271
UDI-Public08717648227271
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
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 Received06/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1550300-23
Device Catalogue Number1550300-23
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 Received07/15/2021
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
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