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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
Model Number 1125400-15
Device Problems Collapse (1099); Unstable (1667)
Patient Problem No Patient Involvement (2645)
Event Date 02/07/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned for analysis. The reported collapse tip was unable to be confirmed; however, the stent was noted to be dislocated on the balloon. 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. Due to the extent of the damage to the stent, it is unlikely that the protective sheath would have fit over the damage; therefore, the damage is not a pre-existing condition. It is likely that the reported tip collapse and noted stent dislocation was a result of inadvertent mishandling of the sds during unpackaging and/or during preparation and 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 4. 0 x 15 mm xience alpine was noted to have a deformed tip upon removal from the dispenser hoop. There was no patient involvement and no clinically significant delay. Returned device analysis noted that the stent was stationary on the balloon, but was not between the markers. 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 Key6676038
MDR Text Key78782506
Report Number2024168-2017-05509
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 06/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/05/2019
Device Model Number1125400-15
Device Catalogue Number1125400-15
Device Lot Number6092741
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
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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