• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1125350-28
Device Problems Difficult To Position; Unstable; Improper or Incorrect Procedure or Method; Physical Resistance; Material Deformation
Event Date 11/19/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant products: guide wire: sion blue, fielder fc. Guide cath: hyperion 6f spb, guideliner 6f v3. Stent: xience alpine 2. 5x23mm. (b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.

 
Event Description

It was reported that the procedure was to treat a concentric, 60mm long de novo lesion, extending from the left main coronary artery (lmt) through the proximal and mid left anterior descending artery (lad). There was heavy calcification, heavy tortuosity and 90% stenosis. After lesion pre-dilatation was performed, two xience alpine stents were successfully implanted, overlapping, in the proximal lad. A 3. 5x28mm xience alpine stent delivery system (sds) was advanced in order to implant it overlapping proximally with the previously implanted stents; however, the sds could not cross the lesion. Additional dilatation was performed and the 3. 5x28mm xience alpine sds was re-inserted into the patient anatomy, but still was unable to reach the distally implanted stent to overlap. Several attempts were made, and it was noted that the guiding catheter and the guideliner appeared to be disengaged from the coronary anatomy. Additionally, angiography indicated the 3. 5x28mm xience alpine stent shifted on the balloon, probably due to guideliner contact with the stent and the proximal end of the stent looked smashed. The sds was inflated and the stent was deployed. Post-dilatation was performed and it was confirmed by ivus that the stent was fully expanded and successfully deployed in the lesion, resulting in 0% stenosis. There was no reported adverse patient effect 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. The loose and damaged stent was unable to be confirmed as the stent was not returned. The difficult to position could not be replicated due to the condition of the returned device. The physical resistance could not be replicated in a testing environment as it was based on operational circumstances. Based on a visual inspection of the returned device, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. 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. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5291793
Report Number2024168-2015-07520
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/21/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/11/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/21/2018
Device Catalogue Number1125350-28
Device LOT Number5051841
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/08/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-