MAUDE Adverse Event Report: INVATEC SPA MO.MA; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE

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

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 01/01/2017

Event Type  Death  

Manufacturer Narrative

Age/date of birth mean age.Sex majority gender journal: carotid stenting in patients with high risk versus standard risk for open carotid endarterectomy (real-1 trial) 0002-9149/17/$ - see front matter 2017 elsevier inc.All rights reserved.Www.Ajconline.Org http://dx.Doi.Org/10.1016/j.Amjcard.2017.04.023.

Event Description

A total of 125 patients were included in this prospective nonrandomized real-word follow-up study.The post-approval carotid artery stenting registry enrolled 71 patients (56%) at ¿standard risk¿ and 54 (44%) at ¿high risk¿ for adverse events from cas, with symptomatic (40%) and asymptomatic (60%) obstructive carotid artery disease.Baseline patient features showed differences between the 2 groups, especially in factors involving ¿high-risk¿ criteria.There were no significant differences in angiographic target lesion characteristics or angiographic outcome after cas between the 2 groups.There were no patients lost to follow-up.The median duration of follow-up was 30 months.Up to 98.4% of the cas procedures were successfully performed, leading to no residual stenosis >30%.The guide could not pass through the stenosis in one of the procedure, and a complete occlusion of the ica was discovered in another patient.General anesthesia and proximal endovascular occlusion was well tolerated by all the patients, with no complication associated.Thrombosis of the eca occurred in 1 procedure in the ¿high-risk¿ group.Transient distal spasm of the ica was detected in 4 cases among the ¿standard-risk¿ group patients and within 1 patient of the ¿high-risk¿ group.None of the ica distal spasm led to any complication, and all of them reassumed their basal diameter spontaneously.During the periprocedural period, the primary end point incidence was similar in both ¿standard-risk¿ and ¿high-risk¿ groups (1.4% vs 1.9%, respectively; hr for ¿standard risk¿ 1.1; 95% ci 0.8 to 1.2, p ¼ 0.77).Two major complications occurred: 1 periprocedural stroke due to ipsilateral embolism, remaining permeable stent and the ica demonstrated by duplex ultrasound, in the ¿standard-risk¿ group, and 1 periprocedural death (ninth day after the procedure) secondary to urinary sepsis in the ¿high-risk¿ group.No mi was reported in either group.Prespecified analysis did not show a modification of the treatment effect in any both ¿standard¿ and ¿high-risk¿ groups by symptomatic status (p ¼ 0.79).During the periprocedural period, primary end point rate did not differ significantly between the ¿standard-risk¿ and ¿high-risk¿ groups among symptomatic patients (hr for symptomatic ¿standard risk¿ 1.02, 95% ci 0.8 to 1.2, p ¼ 0.87).There was no significant difference in the estimated 4- year rate of ipsilateral stroke between the ¿standard¿ and ¿high-risk¿ groups (1.3% vs 1.8%, respectively; hr for ¿standard risk¿ 1.05, 95% ci 0.86 to 1.14, p ¼ 0.9).After the periprocedural period, there was no incidence of new ipsilateral stroke in both groups.The 4-year rate of stroke or death was 4.1% in the ¿standard-risk¿ group compared with 5.6% in the ¿high-risk¿ group (hr 1.2, 95% ci 0.9 to 1.6, p ¼ 0.43).The respective rates were 6.4% and 6.1% among symptomatic patients (hr 1.1, 95% ci 0.8 to 1.4, p ¼ 0.53) and 1.4% and 5.2% among asymptomatic patients (hr 1.13, 95% ci 0.75 to 1.12, p ¼ 0.6).In the multivariate cox regression analysis including age >80 years, gender, and symptomatic carotid artery disease, independent predictors of death and stroke at 30 days were not found.Carotid stenting (cas) has been mainly offered to those patients considered at ¿high risk¿ for open carotid endarterectomy based on available data from large randomized clinical trials.However, several recent studies have called medical ¿high risk¿ into question for cas indication.The real-1 trial evaluated the safety and perioperative and long-term effectiveness in patients with significant carotid artery stenosis with ¿high-risk¿ criteria treated with cas and proximal protection device (moma) compared with those with standard surgical-risk features.This nonrandomized double-arm registry included 125 patients (40% symptomatic), 71 (56%) with ¿standard-risk¿ and 54 (44%) with ¿high-risk¿ criteria.The primary end point was the cumulative incidence of any major adverse event, a composite of stroke, myocardial infarction, and death within 30 days after the intervention or ipsilateral stroke after 30 days and up to 4 years.There was no significant difference in primary end point rate at 30 days between patients at ¿standard risk¿ and those with ¿high risk¿ (1.4% vs 1.9% respectively; hazard ratio for ¿standard risk¿ 1.1; 95% ci 0.8 to 1.2, p [ 0.77) nor estimated 4-year rate of ipsilateral stroke (1.3% vs 1.8%; hazard ratio for ¿standard risk¿ 1.05, 95% ci 0.86 to 1.14, p [ 0.9).Conclusion: in conclusion, 4-year post procedure results demonstrated that cas with proximal device moma is safe and effective for patients with and without ¿high-risk¿ for carotid endarterectomy.

• Brand Name: MO.MA
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): INVATEC SPA; via martiri della libertà, 7; roncadelle,bs 25030 ; IT 25030
• Manufacturer (Section G): INVATEC SPA; via martiri della libertà, 7; roncadelle,bs 25030 ; IT 25030
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6713723
• MDR Text Key: 80040880
• Report Number: 3004066202-2017-00071
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K092177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• 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: 06/15/2017
• 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): Death
• Patient Age: 76 YR