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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 1500225-33
Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Patient Problems Syncope (1610); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
Event Date 08/13/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number (b)(4). The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that a 2. 25x33mm xience sierra stent delivery system (sds) balloon ruptured at 14 atmospheres. The patient lost consciousness and their blood pressure decreased. An injection of adrenaline and cpr were given as treatment. No additional information was provided.
 
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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 Key9012011
MDR Text Key158890674
Report Number2024168-2019-11753
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeFR
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 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/07/2022
Device Catalogue Number1500225-33
Device Lot Number9050141
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 Received11/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2019
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: 09/12/2019 Patient Sequence Number: 1
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