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

Catalog Number 1011344-30

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

Patient Problems Stroke/CVA (1770); Death (1802); Occlusion (1984)

Event Date 10/04/2013

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2013, a 7-10x30mm rx acculink stent was successfully implanted in the right internal carotid artery.On (b)(6) 2013, approximately 7 months post implantation, the patient experienced left hemiparesis, which was diagnosed as a cerebrovascular accident and was hospitalized.The right internal carotid artery was noted to be occluded.Additionally, it was noted that the patient had a history of untreated atrial fibrillation, so coumadin was started.On (b)(6) 2014, the patient was discharged.On (b)(6) 2014, the patient was hospitalized with sepsis and respiratory failure and died.Per the physician, the death was not related to the implanted stent or the stenting procedure.There was no additional information provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported device malfunction, and the product was not returned.The reported patient effects of cerebrovascular accident and occlusion are known observed and potential patient effects as listed in the 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.

Manufacturer Narrative

(b)(4).Manufacturer report number- correct from 3003775027-2014 to 2024168-2014.

• 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: 3927879
• MDR Text Key: 4535958
• Report Number: 3003775027-2014-00037
• 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,Followup
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• 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: 1011344-30
• Device Lot Number: 2022461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2014
• 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: PLAVIX, ASPIRIN
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 65 YR
• Patient Weight: 109