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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1550350-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Syncope (1610)
Event Date 05/13/2019
Event Type  Injury  
Manufacturer Narrative
The stent remains in patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Exemption number (b)(4).
 
Event Description
It was reported that on (b)(6) 2019, the patient presented with an st elevated myocardial infarction (stemi) involving the inferior wall. A 3. 5x18mm xience sierra stent was implanted without reported issues. On (b)(6) 2019, the patient was re-admitted to the hospital due to syncope and collapsing. Unspecified treatment was provided. No further action was reported and the patient was discharged home. No additional information was provided regarding this issue.
 
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Brand NameXIENCE SIERRA
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 Key8958283
MDR Text Key156772565
Report Number2024168-2019-11404
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/25/2019
Device Catalogue Number1550350-18
Device Lot Number8102241
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 Received09/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2018
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: 09/03/2019 Patient Sequence Number: 1
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