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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 1070275-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Arrhythmia (1721); Weakness (2145); Dizziness (2194)
Event Date 08/17/2014
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) 2014, a 2. 75 x 18 mm xience xpedition stent was implanted in the narrow, 80% stenosed, mid, left anterior descending (lad) coronary artery and the patient was discharged on (b)(6) 2014. Information received at the yearly follow-up visits indicates that on (b)(6) 2014, (b)(6) 2015, (b)(6) 2016, (b)(6) 2017 the patient experienced one or more of the following; intermittent anterior cardiac discomfort, chest pain, chest tightness, insomnia, palpitations, light-headedness, weakness, and was admitted each time to the hospital where medical treatment was given and was subsequently discharged a few days later without further intervention. Per the physician, the correlation between events and device is not known. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. A review of the lot history record of the reported device could not be conducted because the lot number was not provided. The reported patient effects of angina and arrhythmia are listed in the xience xpeditiion, 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, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Additional information received states that each time that the patient was hospitalized, they received medication and that there was no coronary angiography was performed. 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 Key7681623
MDR Text Key113770883
Report Number2024168-2018-05277
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,Followup
Report Date 07/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1070275-18
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 Received07/17/2018
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: 07/12/2018 Patient Sequence Number: 1
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