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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1070250-33
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Dizziness (2194)
Event Date 06/05/2018
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 and complaint history could not be conducted because the lot number was not provided. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot 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 on (b)(6) 2014, the patient was hospitalized for chest pain. On (b)(6) 2014, coronary angiography showed 90% stenosis of the mid left anterior descending (lad) coronary artery. A 2. 5x33mm xience xpedition stent and a 3. 0x38mm xience xpedition stent were then implanted in the mid lad. The patient was later discharged from the hospital on (b)(6) 2014. On (b)(6) 2018, the patient was hospitalized for dizziness. Unspecified medication was given; however, coronary angiography and ct were not performed, and the original stent status is unknown. The patient was in good condition and was discharged from the hospital on (b)(6) 2018. There were no adverse patient effects, and there was no reported clinically significant delay in the procedure. Reportedly, the relationship between the event and the device cannot be determined. No additional information was provided.
 
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Brand NameXIENCE XPEDITION 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 Key8440340
MDR Text Key139455945
Report Number2024168-2019-02213
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 03/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1070250-33
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 Received03/06/2019
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: 03/21/2019 Patient Sequence Number: 1
Treatment
STENT: 3.0X38MM XIENCE XPEDITION
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