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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT RX ACCULINK CAROTID STENT SYSTEM

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AV-TEMECULA-CT RX ACCULINK CAROTID STENT SYSTEM Back to Search Results
Catalog Number 1011338-30
Device Problem Break (1069)
Patient Problem Stenosis (2263)
Event Date 08/04/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.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 the left internal carotid artery that did not have any tortuosity or calcification.In-stent restenosis was noted via angiography in a 6.0 x 30 mm acculink ii stent that was previously implanted on (b)(6) 2013.The acculink stent was broken and there was restenosis in the fractured area of the stent and proximal to the stent.The restenosis was therefore treated with a 4.0 x 2.0 mm viatrac peripheral dilatation catheter that was used for pre-dilatation.Then an 8.0 x 6.0 x 30 mm xact stent was implanted in the broken part of the acculink stent.The xact stent was post-dilated with a 5.0 x 20 mm viatrac dilatation catheter at 14 atmospheres to successfully complete the procedure.There was no adverse patient sequela reported.No additional information was provided.
 
Manufacturer Narrative
Internal file number - (b)(4).The device was not returned for analysis.It may be possible that fatigue from artery dynamics and motion may contributed to the stent fracture; however, this could not be confirmed.The lot history record for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.The reported patient effect of restenosis is a known observed and potential patient effect as listed in the rx acculink, domestic, instructions for use.The investigation was unable to determine a cause for the reported stent fracture.The reported restenosis was due to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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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 Key6824922
MDR Text Key83833135
Report Number2024168-2017-07002
Device Sequence Number1
Product Code NIM
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,Followup
Report Date 10/09/2017
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 Catalogue Number1011338-30
Device Lot Number1111651
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/04/2017
Initial Date FDA Received08/28/2017
Supplement Dates Manufacturer Received09/26/2017
Supplement Dates FDA Received10/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Hospitalization; Required Intervention;
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