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

Catalog Number 1011344-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Neurological Deficit/Dysfunction (1982); Pain (1994); Stenosis (2263)

Event Date 01/29/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).There was no reported device malfunction, and the product was not returned.The reported patient effects of headache, neurological deficit/dysfunction, pain, and restenosis are listed in the instructions for use (ifu) as potential adverse events.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.

Event Description

It was reported that on (b)(6) 2012, the patient underwent a stenting procedure with placement of a 7-10 x 40 mm acculink stent in the heavily calcified right internal/common carotid artery.On (b)(6) 2013, the patient presented to the emergency room after experiencing right-sided neck pain which radiated to a severe right periorbital headache/migraine headache, confusion and some memory loss.Diagnosis of encephalopathy and transient ischemic attack were made.Computerized axial tomography, magnetic resonance imaging, magnetic resonance angiography and carotid ultrasound were performed and noted in-stent restenosis.The patient was rehospitalized.Lisinopril was given and plavix was re-started.The patient's metoprolol dosage was decreased.There was no additional intervention performed, although smoking cessation was discussed.The patient will continue to be treated with medications at this time.No additional information was provided.

• 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: 3696570
• MDR Text Key: 18565083
• Report Number: 2024168-2014-01758
• 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: 03/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: 1011344-40
• Device Lot Number: 2053161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 70