MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CRAGG-MCNAMARA; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-CRAGG-MC

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

Patient Problems Hematoma (1884); Intracranial Hemorrhage (1891); Perforation (2001); Insufficient Information (4580)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

Event related to regualtory report: 2029214-2023-01456 see attachments for literature article.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

Patrick cherfan, adham n.Abou ali, mohamed s.Zaghloul, theodore h.Yuo, dennis p.Phillips, rabih a.Chaer, and efthymios d.Avgerinos; journal of vascular surgery: venous and lymphatic disorders; 2021; volume 9, number 3; propofol administration during catheter-directed interventions for intermediate-risk pulmonary embolism is associated with major adverse events; doi.Org/10.1016/j.Jvsv.2020.08.026 medtronic received information in a literature of patients possible treated with cragg-mcnamara catheters had complications including death. the purpose of the present study was to determine whether the choice of anesthetic during these interventions has an effect on the postprocedural outcomes. patients who had undergone catheter-directed intervention (cdi) for acute (submassive) pulmonary embolism (spe) from 2009 to 2019 were identified and grouped according to the intraprocedural use of propofol.The primary outcome was in-hospital intra- or postprocedural major adverse events, defined as the need for intubation, progression to massive pulmonary embolism, and in-hospital death.A total of 340 patients had undergone cdi for acute spe from 2009 to 2019.The mean patient age was 58.74 years, and 174 were men.All the patients had been hemodynamically stable on presentation, and no difference was present in pe magnitude between our two groups as demonstrated using the simplified pulmonary embolism severity index.  of the 340 patients, 36 (10.6%) had received propofol and 304 (89.4%) had not.In the propofol and no-propofol groups, 9 (25%) and 78 (25.65%) had had contraindications to thrombolysis.Procedure: cdis were performed using standard catheters (cragg-mcnamara), ultrasound assisted catheters (ekos), or suction thrombectomy (flowtriever or angiovac). standard procedural techniques, including ultrasoun-guided access of the femoral or internal jugular vein, in addition to heparinization or anticoagulation during and after intervention, were followed as previously described.If deemed necessary, an on-table infusion of 2 to 4 mg of tissue plasminogen activator was pushed, followed by infusion at a rate of 0.5 to 1 mg/hour per catheter.Results: in-hospital outcomes.A total of 18 patients had experienced at least one of the events in our composite outcome.In the propofol group, 5 patients (13.9%) had required postoperative intubation and 2 patients (5.5%) had become decompensated.In the no-propofol group, 5 (1.7%) had required postoperative intubation, 9 (2.9%) had become decompensated, 2 (0.6%) had required open surgical conversion, and 3 (0.9%) had died in-hospital.No difference was found in the incidence of major adverse events between the cases performed in the operating room and those performed in the catheterization laboratory or interventional radiology suite ).Those who had received propofol had had a significantly greater adverse event rate (13.8%).On multivariate logistic regression, propofol was still associated with major adverse events after adjusting for age, contraindications to lysis.A total of 16 major bleeding events, defined using the gusto criteria, had occurred.These included 10 transfusions, 4 hemorrhagic strokes, 1 coronary sinus perforation with progression to cardiac tamponade, and 1 tricuspid valve injury during use of the angiovac cannula (angiodynamics).Other events included six cases of groin hematoma, with two requiring embolization, two cases of knee hematoma that were aspirated, one case of gastrointestinal bleeding, and one case of intraperitoneal bleeding, both of which were managed conservatively.

• Brand Name: CRAGG-MCNAMARA
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17599505
• MDR Text Key: 321713219
• Report Number: 2029214-2023-01457
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-CRAGG-MC
• Device Catalogue Number: UNK-NV-CRAGG-MC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• 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
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male