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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 1125300-23
Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2016
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 is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.

 
Event Description

It was reported that the procedure was to treat a lesion located in the mildly calcified, proximal left anterior descending artery. Predilatation was performed prior to the attempt to cross with the first 3. 0 x 23 mm xience alpine stent delivery system (sds); however, the sds failed to cross the lesion. The second 3. 0 x 23 mm xience alpine sds was attempted to cross; however, it also failed. During retraction from the anatomy resistance was felt which resulted in the stent implant dislodging from the balloon; however, was able to be removed from the anatomy on the sds shaft. A 3. 25 x 23 mm xience alpine sds was able to cross the lesion successfully for treatment of the patient. No adverse patient effects or clinically significant delay in the procedure were reported. No additional information was provided.

 
Manufacturer Narrative

(b)(4). Evaluation summary: the device was returned for analysis. The reported stent dislodgement was able to be confirmed. The reported failure to advance and the reported difficulty to remove were unable to be replicated in a testing environment as they were based on operational circumstances. The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the sds was advanced resistance was met with the mildly calcified anatomy resulting in the reported failure to advance. During retraction, interaction with the anatomy and/or other devices resulted in the noted stent damages (stretched, bent) thus resulting in the reported difficulty to remove and ultimately resulted in the reported stent dislodgement. 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 did not indicate a lot specific quality issue. There is no indication of a product quality issue with respect to manufacture, design or labeling.

 
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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 Key6216563
MDR Text Key63826758
Report Number2024168-2016-09410
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,Followup
Report Date 01/24/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/30/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/06/2019
Device Catalogue Number1125300-23
Device LOT Number6082941
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/28/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2016
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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