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

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

Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770); Embolism (1829); Hemorrhage/Bleeding (1888); Occlusion (1984); Reocclusion (1985); Thrombus (2101); Injury (2348); Vascular Dissection (3160)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

Average age, majority gender, date of publication journal.Article title: acute stroke interventions performed by cardiologists jacc: cardiovascular interventions vol.1 2 , no.1 7 , 2 01 9 ª 2 0 1 9 published by elsevier on behalf of the american colleg e of cardiology foundation.If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this article was to evaluate the technical and clinical success of acute stroke interventions performed on 70 consecutive patients.All patients analysed in this study were out-of-hospital stroke patients.All patients were seen and examined by neurologists in the ed who determined if and what type of diagnostic imaging is necessary and assessed the baseline national institutes of health stroke scale (nihss).Upon detection of a large vessel occlusion (lvo), systemic fibrinolytic therapy was initiated (if not contraindicated).Depending on the angiographic results, the interventionalist decided on the best recanalization strategy.Proximal protection systems were used in almost every patient.In those with both intracranial and extracranial lesions, proximal embolic protection systems were used to provide embolic protection before crossing the lesion to prevent further embolization.Medtronic¿s mo.Ma ultra was use as well as another non-medtronic proximal protection system.Before the target lesion was crossed with a guidewire, both the proximal and distal balloons were inflated, thereby blocking blood flow toward the brain.Using the mo.Ma ultra, flow reversal was created by leaving the stopcock of the working channel open to create a pressure gradient between the arterial pressure in the target vessel and the air pressure in the catheterization laboratory.In patient¿s which only had only an intracranial stenosis, a form of proximal protection was used because the guiding catheters used had a proximal balloon to prevent further embolization.Technical success was defined as restoration of sufficient blood flow in the target vessel.Clinical success was defined as a favourable clinical outcome 3 months after the intervention.The 3-month follow-up examination was at least in the form of a telephone call with the patient, his or her caregiver, or his or her primary care physician(s).In 14 patients, extracranial stenting (for upstream stenosis or dissection) was necessary.In 9 of these cases, a proximal embolic protection device was used to prevent further thromboembolism.In the majority of patients, recanalization¿s of intracranial occlusions were achieved by thrombectomy with a stent retriever.In 20% cases, a continuous aspiration system was used.In 2 patients, recanalization occurred after local (catheter-based intra-arterial) administration of fibrinolytic agents.In 1 of these cases, an attempt at thrombectomy had been made using a stent retriever, but the device could not be delivered due to severe upstream tortuosity.In the other case, cerebral angiography revealed thrombus fragmentation with downstream embolization into multiple distal branches.Therefore, the decision was made to switch from systemic to local fibrinolysis.This case occurred when effective aspiration systems were not yet available.In 28% of cases recanalization was done by a combination of techniques.Access to the supra-aortic arch vessels was achieved in all patients.In 93% of cases, recanalization was technically successful at the end of the intervention.In 4 of the 5 patients who had technically unsuccessful revascularization, no blood flow could be restored in the target vessel despite the use of multiple stent retrievers combined with aspiration.In the fifth patient, an attempt at negotiation of the brachiocephalic trunk was first made via femoral access.Due to a type 3 aortic arch, the brachiocephalic trunk could not be entered with sufficient support.Right radial access was established, and the right common carotid artery successfully engaged, and the device could be delivered to the occlusion.However, despite multiple deployments, the vessel remained occluded.In one patient recanalization was achieved with a 9 x 30 mm stent.Middle cerebral artery thrombectomy was then carried out using another stent.During retrieval, the stent was entrapped by the previously deployed stent struts, disconnected from the delivery system and could not be retrieved.Therefore, a second stent was deployed, trapping the dislodged device between the previously deployed stent and ica wall.Thirty-day mortality was 18%.One patient with a basilar artery stroke, 6 months after basilar stent implantation, the occluded artery could be crossed with a wire and a microcatheter and a stent retriever was deployed but could not be retrieved.The patient deteriorated rapidly and died.One of the previously described patients who had revascularization was technically not possible despite multiple treatment strategies developed severe cerebral edema due to persistent occlusion and died after 3 days.Five patients died of a major stroke despite successful embolectomy.Five patients had a fatal intracranial haemorrhage (diagnosed between 6 h and 2 days after thrombectomy).One patient with known ischemic cardiomyopathy and successful recanalization of a vertebral occlusion died of a ventricular fibrillation arrest within 30 days after the intervention.A favourable clinical outcome was achieved in 37% of patients at the time of hospital discharge.

• Brand Name: MO.MA ULTRA
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer (Section G): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9128330
• MDR Text Key: 161699900
• Report Number: 3004066202-2019-00053
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• 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
• Patient Age: 72 YR