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 Intracranial Hemorrhage (1891); Pseudoaneurysm (2605)

Event Date 08/31/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Akhilesh k sista, oren a friedman, eda dou, brendan denvir, gulce askin, jamie stern, jaclyn estes, arash salemi, ronald s winokur, james m horowitz; vascular medicine; 2018; 23(1) 65¿71; a pulmonary embolism response team¿s initial 20 month experience treating 87 patients with submassive and massive pulmonary embolism; doi: 10.1177/1358863x17730430 medtronic received information in a literature article that a retrospective data review was done.Identified 124 patients who received formal consultations from our pulmonary embolism response team) (pert) between 1 january 2013 and 31 august 2014.43 activations in the first 10 months and 81 in the next 10.A total of 87 submassive (90.8%) and massive (9.2%) pe patients were included.The median age was 65 years.49.4% female. catheter-directed thrombolysis (cdt) was administered to 25 patients, systemic thrombolysis (st) to six, and anticoagulation alone (ac) to 54.Anticoagulation alone was defined by the sole administration of one of the following anticoagulants: heparin, warfarin, enoxaparin, dalteparin, fondaparinux, rivaroxaban, and/or apixaban.Systemic thrombolysis (st) was defined as the administration of 100 mg of recombinant tissue plasminogen activator (rt-pa) infused intravenously over 2 hours or as a bolus in the setting of cardiac arrest.Catheter-directed thrombolysis (cdt) was defined as the placement of multi-sidehole infusion catheters within pulmonary artery thrombus, through which rt-pa was administered.  both ultrasound-assisted catheters (ekowave; from another manufacturer) and standard infusion catheters (unifuse; from another manufacturer or cragg-mcnamara, medtronic,) were employed.Administered 18¿24 mg of rt-pa at a total dose of 1 mg/hour (0.5mg/hour/catheter for two catheters) through the catheter(s), with concomitant infusion of subtherapeutic heparin (goal partial thromboplastin time (ptt) <(><<)>2 times the institutional norm).Mechanical techniques (thrombus maceration) were used in a single patient who became hypotensive upon induction of anesthesia; the rest of the patients undergoing cdt receive d thrombolytic drug infusion only, without maceration or aspiration.The rate of inferior vena cava (ivc) filtration was also recorded.The median intensive care unit (icu) stay and overall length of stay (los) were 6 and 7 days, respectively.Patients who underwent cdt did not differ from those who did not in median icu los (7 vs 5 days) or overall los (7 vs 6.5 days).An elevated bnp (=100 pg/ml) was associated with an 88% increase in icu los (irr = 1.88 (1.2, 3.0), p = 0.008) and a 50% increase in overall los (irr = 1.5 (1.01, 2.2), p = 0.047) after controlling for cdt, heart rate, oxygen saturation, spesi score, and troponin.None of the other variables showed an association with los.Twelve patients died, and there was no significant mortality difference based on treatment allocation.Seven out of eight of those who died in the hospital without thrombolytic therapy carrieddiagnoses of metastatic cancer or primary brain cancer.The single mortality in the st group was attributed to metastatic cancer.One of the patients who underwent cdt had a recurrent fatal massive pe 1 week after the cdt procedure.At the time of cdt, he received an ivc filter.At 23 hours into the cdt infusion, he suffered an episode of major hemoptysis requiring intubation and cessation of anticoagulation.A second borderline s ubmassive/massive cdt patient became hypotensive upon induction of general anesthesia and progressed to cardiopulmonary collapse, and catheter-directed measures were insufficient to rescue him.A third cdt patient was eventually diagnosed with severe chronic thromboembolic pulmonary hypertension and died of progressive cor pulmonale.The overall rate of major bleeding was 5.7%, with one intracranial hemorrhage (subdural) in the st group, one major hemoptysis in the cdt group requiring cessation of anticoagulation (patient described above), and three bleeds requiring transfusion in the ac alone group.One vascular complication happened in the cdt group: a common femoral artery pseudoaneurysm was noted on follow up, likely due to inadvertent arterial puncture.This complication was successfully managed with a percutaneous thrombin injection.

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.

• 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: 14139274
• MDR Text Key: 293726366
• Report Number: 2029214-2022-00655
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940634
• 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: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• 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: 01/10/2023
• 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): Other
• Patient Sex: Male