• 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 RX ACCULINK CAROTID 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 RX ACCULINK CAROTID STENT SYSTEM Back to Search Results
Catalog Number 1011344-40
Device Problem Material Deformation (2976)
Patient Problem Stroke/CVA (1770)
Event Date 07/07/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.A 7-10 x 30 mm acculink stent was advanced, with the thought that perhaps the tapered size would allow the stent to cross, but it was unable.The device was removed without difficulty.The procedure was reviewed and it was noted that the filter had caught on the distal portion of the stent, so that each time the retrieval catheter was pulled to remove, the filter would pop out of the retrieval catheter.The procedure ended with the patient in stable condition.On (b)(6) 2017, the patient began to experience right-sided weakness.Computed tomography (ct) and magnetic resonance imaging (mri) were performed and micro emboli were noted.Cardiovascular accident (cva) was diagnosed.Heparin was administered and the neurologist felt that the event would resolve.The physician will determine if additional intervention, possibly endarterectomy, is needed at a later date.No additional information was provided.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The reported patient effects of cerebrovascular accident, as listed in the instructions for use, is a known adverse event associated with the use of carotid device in native carotid arteries.The investigation was unable to determine a conclusive cause for the reported difficulties and patient effect and there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The emboshield nav6 embolic protection device referenced is filed under a separate medwatch report.
 
Event Description
It was reported that the carotid procedure was performed to treat a target lesion in the mildly calcified and moderately tortuous internal carotid artery.The emboshield nav6 embolic protection device was deployed without issue.The 7.0-10 x 40 mm acculink stent was then deployed without difficulty; however, it was noted that there remained some stenosis and additional dilatation was performed to fully expand the stent to the vessel wall.The emboshield retrieval catheter was advanced to retrieve the emboshield filter; however, there was some resistance noted advancing the retrieval catheter through the acculink stent.The retrieval catheter seemed to be catching on the stent struts.During advancement of the retrieval catheter, the bare wire guide wire and emboshield filter were pulled closer to the distal end of the stent.The retrieval catheter was finally able to advance through the deployed acculink stent and captured the filter.However, as the retrieval catheter was pulled back, it was noted that the filter would pop out of the retrieval catheter.This occurred multiple times.The physician was then able to capture the filter in the retrieval catheter, and pulled with some force to remove the retrieval catheter with the captured filter.It was then noted that the stent was being pulled in on itself at the distal portion.The retrieval catheter and filter were finally able to be removed from the patient anatomy.Multiple balloon dilatation catheters were advanced to the stent and inflated.During inflation, the stent was opened.The dilatation catheters were removed and it was noted that the nitinol in the stent would not allow the stent to remain open at the distal portion of the stent.Additional devices were advanced, but were unable to cross.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RX ACCULINK CAROTID STENT SYSTEM
Type of Device
CAROTID STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
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 Key6759063
MDR Text Key81562933
Report Number2024168-2017-06334
Device Sequence Number1
Product Code NIM
UDI-Device Identifier08717648076398
UDI-Public08717648076398
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040012
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
Report Date 08/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2019
Device Catalogue Number1011344-40
Device Lot Number7040461
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/07/2017
Initial Date FDA Received08/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
-
-