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 Neurological Deficit/Dysfunction (1982); Thrombosis (2100)

Event Date 03/31/2015

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the left internal carotid artery with mild tortuosity and heavy plaque.The patient presented with a transient ischemic attack (tia) 3 weeks prior to the procedure and the vessel had a prior cutdown procedure that had restenosed.The patient was on asa and plavix.An emboshield nav6 filter was advanced distal to the target lesion.Pre-dilatation was performed with a 4 x 20 mm viatrac balloon catheter.The 6 x 8 mm acculink stent was then advanced and deployed in the lesion, without issue.The stent was confirmed to be fully apposed via angiography.Post-dilatation was performed with a 5 x 20 viatrac balloon catheter and a 7 x 20 mm viatrac balloon catheter to lower than nominal pressures.The vessel was checked and thrombus was observed in the distal stent.Heparin was administered and a 4 x 40 mm viatrac balloon catheter was advanced for treatment.The nav6 was removed and angiography was performed, and confirmed the vessel was clear.It was noted that prior to the thrombus, the patient had no issues; however, after the thrombus was observed, the patient showed signs of a transient ischemic attack (tia).Images of the brain were taken and there was no clot or blockage seen.The activated clotting time (act) was taken after the procedure and was noted to be greater than 250.The act was not checked prior to, or during the procedure.The patient was administered tpa and nitro post-procedure, and continues to have right hand/arm deficits which will require rehab.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: dilatation catheter: 5 x 20 mm, 7 x 20 mm viatrac; embolic protection: emboshield nav6.There was no reported device malfunction, and the product was not returned.The reported patient effects of thrombosis and neurological deficit/dysfunction are known observed and potential patient effects as listed in the 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.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.

• 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: 4715123
• MDR Text Key: 18293288
• Report Number: 2024168-2015-02221
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 1011343-40
• Device Lot Number: 4110361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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