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 Problem Stenosis (2263)

Event Date 09/08/2014

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2013, an acculink stent was successfully implanted in the left internal carotid artery lesion and the patient was discharged home the following day.On (b)(6) 2014, the patient was hospitalized and revascularization, with stent placement, was performed in 82% re-stenosed, acculink stent.The patient was discharged home the following day.The condition was noted as continuing.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.(b)(6).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The investigation was unable to determine a conclusive cause for the reported patients affects and the treatment appears to be due to operational context.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.The reported patient effect of stenosis, as listed in the css, rx acculink, domestic, instructions for use (ifu) is a known patient effect.Although a conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined, there is no indication the issue was caused by or related to the design, manufacture or labeling of the device.

• 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 Key: 4951219
• MDR Text Key: 21796001
• Report Number: 2024168-2015-04249
• 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,health professional,stu
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: 1011344-40
• Device Lot Number: 2061561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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: 101