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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 1120275-15
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 03/20/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device was not returned 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. Additionally, a review of the complaint history identified no other similar incidents from this lot. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Manufacturer Narrative
(b)(4). The investigation determined the reported difficulties appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Subsequent to the final report, additional information was received reporting that the xience alpine could not cross the lesion.
 
Manufacturer Narrative
(b)(4). The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion in the circumflex (cx) artery. During positioning of the xience alpine 2. 75 x 15 mm in the cx, the stent detached from the stent delivery system balloon and embolized distally. As the stent could not be recovered, it was compressed without any problems. There was no adverse patient sequela. 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 Key6563284
MDR Text Key106073465
Report Number2024168-2017-04105
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIT
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 08/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/06/2019
Device Catalogue Number1120275-15
Device Lot Number6112541
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 Received08/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2016
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: 05/12/2017 Patient Sequence Number: 1
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