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

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.

• 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 Key: 4010792
• MDR Text Key: 19722204
• Report Number: 2024168-2014-05203
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• 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 Date: 01/31/2014
• Device Catalogue Number: 1011343-40
• Device Lot Number: 3021461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2014
• Initial Date FDA Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EMBOLIC PROTECTION: TWO RX ACCUNET
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 81