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

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

Patient Problem Vascular Dissection (3160)

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

Absolute and relative contraindications to proximal protection: do they really matter? a case-illustrative approach minerva cardiology and angiology 2022 december;70(6):738-50 doi: 10.23736/s2724-5683.22.06222-6 © 2022 edizioni minerva medica online version at https://www.Minervamedica.It b3 date of publication.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a literature article titled 'absolute and relative contraindications to proximal protection: do they really matter? a case-illustrative approach'.The article discusses cas periprocedural variables and how the type of cerebral protection ¿ distal filter and proximal protection ¿ play a pivot role to reduce cerebral embolization.The paper discusses how to identify, treat, and overcome technical obstacles that are believed to contribute to the low rate of worldwide penetration of the device.The use and procedural steps for the mo.Ma ultra proximal protection system, its indications/strengthens and how to manage the contr aindications/weaknesses of the device are discussed.Eca/cca dissection this is a rare event that occurred in one case in >(b)(4) treated with pp at our academic center.As shown in the figure 12, a non-flow limiting dissection of proximal eca was detected at the end of procedure right at the level of the balloon marker.Since the patient was symptomatic and the blood flow unimpeded, we choose a ¿wait-andsee¿ policy maintaining the protocol anticoagulation.The most probable cause was an incomplete air aspiration during eca balloon preparation.The entrapped air did not allow to see the balloon shape modification during inflation leading to balloon elongation (as shown by the length of the gap at the angiographic occlusion test) associated with overdistention.The doppler ultrasound at 24 hours confirmed a good eca blood flow with no residual dissection.To avoid this type of complication we suggest to: 1) meticulously check of eca/cca balloon contrast filling avoiding residual air bubbles; 2) use the t-safety connector during balloon inflation; and 3) stop inflation when the balloon shape becomes cylindric (not obtainable in this case).We never experienced a mo.Ma-induced dissection of the cca.In case of flow-limiting dissection or perforation of eca collaterals a 0.035¿ coronary wire should be navigated through the stent struts followed by a 3.0 x 20 mm balloon to be inflated at the bleeding site.Partial or full reversal of anticoagulation by patient-weight with protamine may help in case of bleeding.Difficult to position in complex anatomy originally put on the market as a 11f device, the size was reduced overtime to 8f improving navigation while maintaining good contrast opacification and blood pressure recording.The 8f version can accommodate 5f-compatible carotid stents, such as the closed-cell design carotid wallstent 8 mm, the open-cell design precisepro 8 mm and the dual-layer design roadsaver stent, all sizes.A carefulpre-cas assessment of target carotid anatomy with ctangiography is mandatory to set a proper strategy.We assessed the feasibility and safety and the 8f mo.Ma system from radial/brachial approach in specific anatomic settings with favorable device success and low crossover to femoral approach rate matching data obtained with trcas with distal filter or transfemoral cas with proximal protection.Notably, we failed to engage the target vessel at the first attempt in (b)(4) of patients in complex vascular anatomy.Thus, the standard technique was modified removing the mandrel and adding a second wire (the so-called no-mandrel two wire technique) achieving high rate of success.

• Brand Name: MO.MA ULTRA
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18158156
• MDR Text Key: 328351298
• Report Number: 9612164-2023-05351
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K092177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• 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: 11/07/2023
• 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