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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 1011343-40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100)
Event Date 07/12/2013
Event Type  Injury  
Event Description
It was reported that during placement of an rx acculink stent in the 99% stenosed lesion in the left internal carotid, the patient experienced bradycardia.Atropine was administered and the bradycardia resolved.After stent deployment, hypotension, a distal edge dissection and thrombus was noted.Thrombectomy was performed and a non-abbott stent was placed, treating the dissection.Neosynephrine was given for the hypotension.One day post procedure, the hypotension resolved and the patient was discharged home.There was no additional information provided.
 
Manufacturer Narrative
(b)(4).There was no reported device malfunction, and the product was not returned.The reported patient effects of dissection, bradycardia, hypotension and thrombosis are known observed and potential patient effects as listed in the ifu, css, rx acculink, domestic, instructions for use (ifu).Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality deficiency with respect to manufacturing, 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 462
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
abbott vascular
26531 ynez road
temecula CA 92591 462
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key4010792
MDR Text Key19722204
Report Number2024168-2014-05203
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 Study,Health Professional
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 07/30/2014
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? No
Device Operator Health Professional
Device Expiration Date01/31/2014
Device Catalogue Number1011343-40
Device Lot Number3021461
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/30/2014
Initial Date FDA Received08/14/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
EMBOLIC PROTECTION: TWO RX ACCUNET
Patient Outcome(s) Required Intervention;
Patient Age73 YR
Patient Weight81
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