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 Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Respiratory Failure (2484)

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

See manufacturer report # 2029214-2022-00672 for another event from this article.Liang nl, chaer ra, chaer lk, singh mj, makaroun ms, avgerinos ed.Midterm outcomes of catheter-directed interventions for the treatment of acute pulmonary embolism.Vascular.2017;25(2):130-136.Doi:10.1177/1708538116654638.If information is provided in the future, a supplemental report will be issued.

Event Description

Liang nl, chaer ra, marone lk, singh mj, makaroun ms, avgerinos ed.Midterm outcomes of catheter-directed interventions for the treatment of acute pulmonary embolism.Vascular.2017;25(2):130-136.Doi:10.1177/1708538116654638.Medtronic literature review found a report of patient complications in association with cragg-mcnamara infusion catheter.The purpose of this article was to report midterm outcomes of catheter directed thrombolysis for treatment of acute pulmonary embolism (pe).A total of 69 were included in the study.The average age was 59 years, and the majority were female (39).Of these, 36 patients underwent ultrasound-accelerated thrombolysis (usat), 27 patients had standard catheter-directed thrombolysis (cdt), and 6 patients had aspiration thrombectomy, rheolysis, or catheter- directed on-table single-dose thrombolytic therapy performed.Cdt procedures requiring continuous infusion of thrombolytic were accomplished using the cragg-mcnamara or unifuse catheters.It is unclear how many of each were used.  the article does not state any technical issues during use of the cragg-mcnamara infusion catheter.The following intra- or post-procedural outcomes were noted: - two patients died perioperatively: one patient with intermediate-risk pe successfully completed usat with a good initial result but suffered a sudden cardiac arrest and death just prior to anticipated discharge.The other patient presented with high-risk pe and hemodynamic instability, arresting and expiring on the operating room table after initial placement of catheters and delivery of alteplase loading dose but prior to initiation of continuous lytic infusion.- the estimated overall survival was 96.8% at 30 days, 90.3% at 90 days, and 81.2% at one year.- six patients, all undergoing cdt or usat, met criteria for hemodynamic decompensation after initiation of catheter-directed therapy.Of these six, three had high-risk pe with preexisting hemodynamic instability, and three had new-onset postoperative hypotension.Two of these patients died as mentioned previously, one before and one after initiation of continuous lytic infusion; three patients progressed to surgical embolectomy; and one patient recovered without intervention and was discharged to a long-term acute care facility.The median length of icu stay was two days.Hemodynamic decompensation was defined as new-onset sustained hypotension, new requirement for inotropes or vasopressors, or continued or worsening hypotension despite treatment.- eight patients met criteria for a major non-mortality adverse event: three surgical embolectomy, two major bleeding events requiring intervention or transfusion, two patients with respiratory failure requiring tracheostomy, and one patient with a tricuspid valve rupture after suction thrombectomy with the angio-vac device requiring valve replacement.- there were six minor bleeding events, which was defined as all other clinically significant bleeding events without need for transfusion or intervention.- two patients had documented recurrent pe events during the follow-up period.

Manufacturer Narrative

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

Additional information received reported that the manufacturer was unknown but no adverse events were related to the product.

• 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: 14162307
• MDR Text Key: 289698922
• Report Number: 2029214-2022-00673
• 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,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• 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: 04/21/2022
• 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): Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female