• 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 PROX EVEROLIMUS ELUTING RX 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 PROX EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1076250-28
Device Problems Physical Resistance; Device Dislodged or Dislocated
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed. Based on the information provided and without the product to examine, the reported difficulties appear to be related to circumstances of the procedure and not a product quality issue with respect to manufacture, design or labeling and the treatment appears to be related to the operational context 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 did not indicate a lot specific quality issue. Based on the information reviewed, there is no evidence to indicate the presence a potential quality issue with respect to manufacture, design or labeling. The xience prox is currently not commercially available in the u. S. ; however, it is similar to a device sold in the u. S.

 
Event Description

It was reported that the procedure was to treat a lesion located in the proximal left anterior descending artery that was heavily tortuous and heavily calcified. Predilatation was performed prior to the attempt to stent. The 2. 5 x 28 mm xience prox stent delivery system (sds) was advanced; however, could not be placed exactly in the stenosis. The vessel distal to the lesion was also very calcified and tortuous and during the attempt to position the sds moving it back and forth, the stent implant dislodged from the balloon. The stent delivery system balloon was advanced distal to the stent in an attempt to pull the stent proximally which resulted in the stent moving about 1. 5 cm. A bigger diameter balloon was then placed inside the dislodged stent and an attempt was made to remove the stent and guide wire as one unit, but this was not possible. The decision was made to compress the stent against the vessel wall in the left main artery and proximal lad using this bigger balloon. Another stent were placed in the left main and the proximal lad in the original stenosis. A third stent was then placed in the the circumflex artery with good result. The patient is reported to be fine. There was no clinically significant delay in the procedure reported. No additional information was provided.

 
Manufacturer Narrative

(b)(4). Evaluation summary: the device was returned for analysis. The reported dislodged stent was able to be confirmed. The reported physical resistance was unable to 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 manufacture, design or labeling. Based on the information provided, the reported difficulties appear to be related to circumstances of the procedure and not a product quality issue with respect to manufacture, design or labeling.

 
Event Description

Subsequent to the previously filed medwatch report new information received as follows: the dislodged stent was able to be pushed with the balloon partially in the lesion and partially in healthy tissue where it was crushed against the vessel wall with the balloon.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameXIENCE PROX EVEROLIMUS ELUTING RX 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 Key5378238
Report Number2024168-2016-00357
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 02/10/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/19/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/26/2017
Device Catalogue Number1076250-28
Device LOT Number4091741
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/28/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/19/2016 Patient Sequence Number: 1
-
-