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

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

Patient Problems Hematoma (1884); Stenosis (2263)

Event Date 02/11/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Patient presented with persistent left neck pain without any apparent trigger.Magnetic resonance (mr) angiography demonstrated severe stenosis in the left cervical ica.Source images of mr angiography revealed the presence of an intimal flap as well as an intramural hematoma.Digital subtraction angiography demonstrated long severe stenosis of the left cervical ica, resulting in profound flow restriction.Based on these findings, patient was diagnosed with ica dissection.As cerebral hypoperfusion was prominent, and it was decided to perform carotid artery stenting.Endovascular therapy was performed under local anesthesia via the transfemoral route.A 9fr balloon guiding catheter (mo.Ma ultra) was navigated to the common carotid artery (cca).Under cca and external carotid artery balloon occlusion, a guardwire was introduced into the high cervical ica.The entire procedure was subsequently performed with distal balloon protection.Balloon angioplasty with a non-medtronic 4.5 mm × 30 mm was performed along the full length of the stenosis.Protégé 8 × 60 mm was deployed to cover the entire length of the stenosis.However, angiography under the distal balloon protection revealed prominent stenosis just proximal to the stent, where dissection was not involved in preoperative angiography.At first, it was assumed that intramural hematoma was protruded to the true lumen due to stenting, they aspirated the blood using a suction catheter, neither debris nor clot was confirmed in the aspirated blood.Thus, the stenosis was suspected to be caused by the intramural hematoma which might have been mobilized longitudinally through the pseudolumen.Additional stent placement with protégé 10 × 40 mmwas performed to fully cover the newly arising stenosis, and telescoped to the initial stent.Postoperative angiography demonstrated complete recanalization of the lesion without any flow restriction.The patient had a favorable postoperative course without neurological deficits.Postoperative source mr angiography images revealed that the intramural hematoma was trapped and shifted laterally by the stent, even in the preoperatively intact ica.

• Brand Name: MO.MA ULTRA
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14758291
• MDR Text Key: 295020229
• Report Number: 3004066202-2022-00002
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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: 05/25/2022
• 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: 46 YR
• Patient Sex: Female