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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA STENT 3.5 X 38 CARDIAC CORONARY DRUG-ELUTING STENT

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ABBOTT VASCULAR XIENCE SIERRA STENT 3.5 X 38 CARDIAC CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 1550350-38
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/05/2021
Event Type  malfunction  
Event Description
Pt brought to operating room 5 for angiogram with stent placement. Coronary stent brought from cath lab. Stent aligned in patient but failed to deploy. Fda safety report id # (b)(4).
 
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Brand NameXIENCE SIERRA STENT 3.5 X 38
Type of DeviceCARDIAC CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
ABBOTT VASCULAR
MDR Report Key11817269
MDR Text Key250686583
Report NumberMW5101318
Device Sequence Number1
Product Code NIQ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1550350-38
Device Catalogue Number1550350-38
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

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