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

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

Patient Problems Intracranial Hemorrhage (1891); Stenosis (2263)

Event Date 04/01/2007

Event Type  Injury  

Event Description

This event was captured based upon review of the article, ct perfusion-guided versus time-guided mechanical recanalization in acute ischemic stroke patients.It was reported that a retrospective study was performed to compare the safety and efficacy of ct [computed tomography] perfusion (ctp)-guided to time-guided mechanical recanalization in acute ischemic stroke (ais) patients.Patients from the stroke database of this site were reviewed from (b)(6) 2007 through (b)(6) 2012, with 132 patients, 94 undergoing ctp-guided and 38 undergoing time-guided mechanical recanalization recruited to the study.The rate of partial-to-complete recanalization did not differ between the ctp and the non-ctp group (78.7% vs.81.6%, respectively).Ich [intracranial hemorrhage] occurred respectively in 18.1% in the ctp group versus 31.6% in the non-ctp group.The overall in-hospital mortality rate was significantly lower in the ctp group (15.9% vs.36.8%).The study conclusions were that ctp-based patient selection was associated with lower ich and mortality rates.Favorable outcomes, however, did not differ between the 2 groups.These results may suggest a possible benefit in terms of in-hospital mortality with ctp-guided triage of ais [acute ischemic stroke] patients for endovascular treatment.This report represents the 75 potential clinical outcomes of restenosis with treatment and intracranial hemorrhage related to the acculink stent.

Manufacturer Narrative

(b)(4).Mean age for ctp group was 66.5, for non-ctp group was 63.5.Female gender for ctp group was 58 patients, for non-ctp group was 19 patients.Male gender for ctp group was 36 patients, for non-ctp group was 19 patients.Date of event is estimated as (b)(6) 2007.Patients reviewed underwent mechanical thrombectomy between (b)(6) 2007 and (b)(6) 2012.Mean national institutes of health stroke scale (nihss) for ctp group was 16.0, for non-ctp group was 17.1.Iv-tpa for ctp group was 44, for non-ctp group was 15.Site of occlusion: middle cerebral artery: ctp patients was 59, non-ctp patients was 20.Internal cerebral artery: ctp patients was 15, non-ctp patients was 10.Basilar artery: ctp patients was 7, non-ctp patients was 8.Multiple occlusions: ctp patients was 13, non-ctp patients was 0.Date of implant is estimated as (b)(6) 2007.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.Reviews of the lot history record and complaint history could not be conducted because the lot number was not provided.This incident was reported with the absence of any device malfunction.As a result, a similar incident query is not required as the complaint details and the lot history record review did not reveal a potential device relationship to the reported incident.The reported patient effects of hemorrhage and restenosis are listed in the rx acculink, domestic, 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 deficiency with respect to manufacturing, design or labeling.Based on the information reviewed, there is no indication of a product deficiency.

• Brand Name: 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: 3680343
• MDR Text Key: 4298919
• Report Number: 2024168-2014-01559
• 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: Literature
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention