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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1125400-28
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Dyspnea (1816); Dizziness (2194); Stenosis (2263)
Event Date 02/19/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The product was not returned to abbott vascular for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. There was no reported device malfunction. The reported patient effects of angina, dyspnea, dizziness, and stenosis are listed in the xience pro a instructions for use, as known patient effects. A conclusive cause for the 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.
 
Event Description
It was reported that the procedure on (b)(6) 2018 was to treat a de novo lesion located in the mid right coronary artery (rca) with 90% stenosis. A 4. 0x28 mm xience alpine stent was implanted. On (b)(6) 2019 the patient went to the emergency room with shortness of breath, dizziness, and arm pain that were diagnosed as angina. On (b)(4) 2019 percutaneous coronary intervention was performed to revascularize the restenosis in the rca target lesion. A non-target lesion was also treated. The condition resolved on (b)(6) 2019. No additional information was provided.
 
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Brand NameXIENCE ALPINE 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 Key8417988
MDR Text Key138706908
Report Number2024168-2019-01990
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/19/2020
Device Catalogue Number1125400-28
Device Lot Number7021341
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 Received02/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2017
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: 03/13/2019 Patient Sequence Number: 1
Treatment
ASPIRIN, CLOPIDOGREL
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