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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 1125325-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 10/03/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. 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. A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

 
Event Description

It was reported that a 3. 25 x 18 mm xience alpine stent was implanted on (b)(6) 2016. On (b)(6) 2016 the patient was re-admitted due to an accidental overdose; however, there were other unspecified cardiovascular symptoms. It is unknown what treatment was performed or what the final patient outcome was. 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)
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 Key6216663
MDR Text Key63691993
Report Number2024168-2016-09430
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial
Report Date 12/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/04/2019
Device Catalogue Number1125325-18
Device LOT Number6012061
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 Received12/20/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2016
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: 12/30/2016 Patient Sequence Number: 1
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