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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 1550225-23
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Dyspnea (1816); Pain (1994); Dizziness (2194)
Event Date 12/01/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned for evaluation. A review of the lot history record was not performed because the lot number was not reported. The reported patient effects of angina and pain are listed in the xience sierra, everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures. A conclusive cause for the reported patient effects, and the relationship to the product, if any, could not be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
 
Event Description
It was reported that the patient had three xience sierra stents (2. 25x23 mm (x2), 2. 50x12 mm) implanted in an unspecified coronary artery on (b)(6) 2018 and has not been able to sleep, feeling dizzy and light headed, shortness of breath, chest pain and access site tenderness in the femoral artery since the procedure. The patient does not have any known allergies to metal. On (b)(6) 2018 the patient went to the emergency room and echocardiogram was performed. No further intervention was performed as the pain was reported to be likely from healing from the stents being implanted. The patient was given nitroglycerin for the chest pain and discharged from the hospital on (b)(6) 2018. As of (b)(6) 2018, the patient is feeling better but still experiencing shortness of breath. No additional information was provided.
 
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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)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key8175253
MDR Text Key130697807
Report Number2024168-2018-09803
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1550225-23
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2018
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: 12/18/2018 Patient Sequence Number: 1
Treatment
STENT: XIENCE SIERRA (2.25X23 MM, 2.50X12 MM)
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