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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ACCULINK; CAROTID STENT

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ABBOTT VASCULAR ACCULINK; CAROTID STENT Back to Search Results
Catalog Number 1010133-40
Device Problems Material Separation (1562); Malposition of Device (2616)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 10/11/2019
Event Type  Injury  
Manufacturer Narrative
(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 moderately calcified lesion in the moderately tortuous common carotid artery.An emboshield nav6 was placed in the left internal carotid artery without issue.An acculink stent was then advanced and released without issue; however, the lesion was not fully covered.Another 7x10x40 mm acculink stent was advanced without issue but there was difficulty deploying the device.The delivery system was removed and it was found that the stent had been deployed in the common carotid artery.It was attempted to remove the stent; however, it fractured and about 10 cm remained in the patient.The patient was sent for surgery to have the remaining portion removed.No additional information was provided.
 
Manufacturer Narrative
Visual analysis was performed on the returned device.The reported material separation was confirmed.The malposition of the device was not able to be confirmed as it was based on procedural circumstances.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 identified no other incidents and/or complaints.The investigation determined that the reported difficulties were related to case circumstances.It is likely that interaction with the first implanted acculink stent contributed to the difficulty and caused the distal outer sheath to tear and separate.As a result, the stent deployed in the common carotid artery during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Corrections: b5 - event description; d7- explant date removed.
 
Event Description
Correction: the acculink stent implant did not separate, but was deployed and remains implanted in the common carotid artery.The acculink delivery system [shaft] separated and the 10 cm that remained in the patient was removed surgically.No additional information was provided.
 
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Brand Name
ACCULINK
Type of Device
CAROTID STENT
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key9269337
MDR Text Key164721637
Report Number2024168-2019-13124
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
PMA/PMN Number
P040012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/24/2020
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 Date02/28/2021
Device Catalogue Number1010133-40
Device Lot Number9032761
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2019
Initial Date Manufacturer Received 10/11/2019
Initial Date FDA Received11/01/2019
Supplement Dates Manufacturer Received01/14/2020
Supplement Dates FDA Received01/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EMBOSHIELD NAV6.; EMBOSHIELD NAV6
Patient Outcome(s) Required Intervention;
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