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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1011706-12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Headache (1880); Dizziness (2194)
Event Date 03/14/2016
Event Type  Injury  
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 of angina is listed in the xience prime small vessel (sv) everolimus eluting coronary stent system (eecss), instructions for use (ifu) as a known patient effect 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 of the device.
 
Manufacturer Narrative
(b)(4). The date was filed incorrectly on the initial medwatch report as (b)(4) 2017, but should have been (b)(4) 2017.
 
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) 2013, the patient was admitted with paroxysmal chest pain of 10 years and exacerbated for one month. Coronary angiography was performed on (b)(6) 2013 and a 2. 25 x 12 mm xience prime stent was implanted in the middle right coronary artery (rca). The patient was discharged on (b)(6) 2013. On (b)(6) 2016, the patient was re-hospitalized with a two-month history of chest pain, headache and dizziness. Medications were administered and the patient was discharged to home on (b)(6) 2016. No additional information was provided.
 
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Brand NameXIENCE PRIME SV 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 Key7188477
MDR Text Key110629624
Report Number2024168-2018-00357
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,Followup
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/17/2016
Device Catalogue Number1011706-12
Device Lot Number3071041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
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: 01/12/2018 Patient Sequence Number: 1
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