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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 1125325-33
Device Problems Collapse (1099); Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/18/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. 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 mildly tortuous, moderately calcified, de novo, 90% stenosed lesion in the mid left anterior descending artery. After the xience alpine 3. 25 x 33 mm was implanted, the kissing balloon technique (kbt) was performed with the stent delivery balloon catheter and another balloon catheter. However, the xience alpine stent delivery balloon deflation took time. There was no deflation issue after stent deployment. Eventually, the balloon was completely deflated using a 30cc syringe. The shaft was found to be crushed. There were no adverse patient affects and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned for analysis. Visual, dimensional, and functional inspections were performed on the returned device. The shaft damage was confirmed however the deflation issue was not confirmed. 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. The investigation was unable to determine a conclusive cause for the reported deflation issues however the shaft damage appears to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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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 Key6407367
MDR Text Key70303369
Report Number2024168-2017-02143
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 04/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/17/2019
Device Catalogue Number1125325-33
Device Lot Number6011241
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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