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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1011711-23
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Arrhythmia (1721); Dizziness (2194)
Event Date 07/12/2017
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 relevant information.
 
Event Description
It was reported that on (b)(6) 2014, a 4. 0x23mm xience prime stent was successfully implanted in the proximal left anterior descending (lad) coronary artery lesion. Starting on (b)(6) 2017, the patient experienced intermittent chest tightness (diagnosed as unstable angina) with palpitations and dizziness lasting 5 days. On (b)(6) 2017, the patient was hospitalized for this event and medications were provided. Coronary angiography was not performed. The event resolved and on (b)(6) 2017, the patient was discharged from the hospital. No additional information was provided regarding this issue.
 
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effect(s) of angina and arrhythmias are listed in the xience prime, xience prime small vessel (sv), and xience prime long length (ll), everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect(s) of coronary stenting procedures. 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.
 
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Brand NameXIENCE PRIME 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# 9616693
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 Key7694434
MDR Text Key114183815
Report Number2024168-2018-05508
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 foreign,health professional,s
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/25/2015
Device Catalogue Number1011711-23
Device Lot Number3041741
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 Received07/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2013
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: 07/17/2018 Patient Sequence Number: 1
Treatment
ASPIRIN
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