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); Unspecified Infection (1930); Pseudoaneurysm (2605); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

Franziska heidemann, tilo kölbel, e.Sebastian debus, holger diener, sebastian w.Carpenter, fiona rohlffs, nikolaos tsilimparis; journal of endovascular therapy; 2018; 25(4) 466¿473; renal function salvage after delayed endovascular revascularization of acute renal artery occlusion in patients with fenestrated-branched endovascular aneurysm repair or visceral debranching; doi.Org/10.1177/1526602818783506.Medtronic received information in a literature article that patients potentially receiving treatment with a cragg-mcnamara catheter experienced complications including pneumonia, urinary tract infection, pseudoaneurysm, subarachnoid hemorrhage, and death.7 patients (mean age 61 years, range 49¿72; 5 women) with renal artery occlusion (rao) were treated between december 2014 and march 2017.3 of the 7 were treated with the medtronic catheter. revascularization of the rao was performed using aspiration thrombectomy, local lysis therapy, and stent-graft relining.  after aspiration, all renal arteries received local intra-arterial lysis with a bolus of recombinant tissue-type plasminogen activator (rt-pa).In selected cases, a multiport cragg-mcnamara catheter was left in place to continue rt-pa infusion up to 24 hours. continued intra-arterial lysis due to residual thrombus burden was needed in 3 patients, including both procedures in the visceral debranching patient.Lysis therapy was continued for 12 to 14 hours in 2 patients with 1 mg/h rt-pa, while the third was continued for 24 hours (0.5 mg/h rt-pa).There were no intraoperative complications. one patient developed pneumonia and urinary tract infection.There were no bleeding complications, but 1 access-related pseudoaneurysm of the right brachial artery was treated with thrombin injection.No early reintervention on the target renal artery was necessary. patient 1 died 10 days after intervention due to hypoxia and cardiac arrest of unknown cause and subarachnoid hemorrhage after resuscitation.This patient had a good final angiography and improvement in urine output postoperatively after initial dialysis dependency (86% 30-day survival).

Manufacturer Narrative

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

Event Description

Patient 5 died 5 months after discharge of an unknown cause (visits to his general practitioner were uneventful and without suspicion of aki).

Manufacturer Narrative

G3 510k information corrected.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.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: 14079576
• MDR Text Key: 289053317
• Report Number: 2029214-2022-00615
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• 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?: No
• 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): Death
• Patient Age: 61 YR
• Patient Sex: Female