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 Pain (1994); Visual Disturbances (2140); Stenosis (2263)

Event Date 06/17/2015

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2012, the patient underwent a carotid artery stenting procedure, with placement of a 7-10 x 40 mm acculink stent in the right internal carotid artery.On (b)(6) 2015, the patient experienced 1-2 hours of transient right-sided visual field loss with right eye pain and intraocular pressure.An ultrasound was performed and concluded right carotid artery critical stenosis.Computerized tomographic angiography confirmed a high-grade right internal carotid artery in-stent restenosis.Medication was administered.The patient underwent a carotid endarterectomy and the patient condition resolved on (b)(6) 2015.No additional information was provided.

Manufacturer Narrative

(b)(4).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 difficulties / issue.A review of the lot history record revealed no non-conformances or exceptions that would have contributed to the reported event.The reported patient effects of pain, visual disturbances and stenosis are known observed and potential patient effects as listed in the rx acculink instructions for use.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 issue with respect to manufacture, design or labeling.(b)(4).

Event Description

Subsequent to the initial report, information was received, which indicates that the acculink stent was explanted during the carodid endarterectomy procedure on (b)(6) 2015.

• 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: 4944121
• MDR Text Key: 6635827
• Report Number: 2024168-2015-04194
• 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: 08/14/2015

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: 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
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 07/27/2015
• 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: 72 YR
• Patient Weight: 70