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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 1125250-38
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Non specific EKG/ECG Changes (1817); Thrombosis (2100)
Event Date 12/11/2017
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 effects of angina and thrombosis are listed in the xience alpine 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 and there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that during balloon pre-dilatation of the 90% stenosis in the heavily calcified, distal left circumflex coronary artery, the patient experienced st elevation. A 2. 50x38 mm xience alpine stent was successfully deployed, reducing stenosis to 0%. Post-dilatation was not performed. About twenty minutes post procedure, the patient experienced chest pain with st elevation, and was brought back to the cath lab. Activated clotting time (act) was noted to be at 214 seconds with a timi 3 blood flow. Additional heparin was administered. An occlusion/clot was unable to be visualized; however, the physician suspected either a clot or unseen calcium behind the stent may have caused the st elevation. Post stent balloon dilatation was performed and the chest pain and st elevations resolved. An intravenous infusion of integrilin was started. In the opinion of the physician, the stent did not cause or contribute to the patient event. The physician believes the event was due to inadequate anti-coagulation and residual calcium in the vessel. The patient was discharged home on (b)(6) 2017 and was doing great. There was no additional information 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 Key7153391
MDR Text Key96002709
Report Number2024168-2017-10153
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 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/01/2020
Device Catalogue Number1125250-38
Device Lot Number7072141
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 Received12/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2017
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: 12/28/2017 Patient Sequence Number: 1
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