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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM

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AV-TEMECULA-CT XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1074350-38
Device Problems Difficult to Insert (1316); Unstable (1667); Material Deformation (2976); Physical Property Issue (3008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. 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 of the reported lot did not indicate a lot specific quality issue. 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
It was reported that the procedure was to treat an unknown lesion. As the xience xpedition 3. 5 x 38 mm stent delivery system (sds) was advanced through the co-pilot into the guide catheter, it felt gritty. Thus, the sds was removed from the catheter and it was observed that some of the distal struts were flared. The sds was never advanced into the body of the patient, only advanced a small length of the guide catheter outside the body. A new stent delivery system was then opened and deployed without issue. There were no reported adverse patient effects and no clinically significant delay in the procedure. No additional information was provided. Based on a photo received from the account, the stent had moved distally on the balloon.
 
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Brand NameXIENCE XPEDITION 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 Key7260867
MDR Text Key100039426
Report Number2024168-2018-00966
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCA
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
Report Date 02/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/29/2020
Device Catalogue Number1074350-38
Device Lot Number7112741
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 Received01/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2017
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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