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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM

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AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1500300-23
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Intimal Dissection (1333); Cardiac Enzyme Elevation (1838); Occlusion (1984)
Event Date 01/09/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. 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 on (b)(6) 2019, pre-dilatation was performed in the mid left anterior descending (lad) coronary artery lesion. A 3. 0x23mm xience sierra stent was implanted in the mid lad. Following, stent underexpansion and a proximal stent dissection were noted. As treatment, post-dilatation was performed and a 4. 0x18mm xience sierra stent was implanted. Acceptable procedure results were reported. Post procedure, elevated troponin was observed. An electrocardiogram was performed. There was no reported myocardial infarction. Reportedly, the troponin elevation was due to a loss of the diagonal branch related to the 3. 0x23mm xience sierra stent underexpansion. Per physician, the troponin elevation was not serious and required no further treatment. 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 SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
CLONMEL,IRELAND REG# 3005718570
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
lindsey bell
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key8776267
MDR Text Key150567895
Report Number2024168-2019-05501
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 foreign,health professional,s
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/29/2021
Device Catalogue Number1500300-23
Device Lot Number808164
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 Received09/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2018
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: 07/10/2019 Patient Sequence Number: 1
Treatment
GUIDE CATH: 5FR
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