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); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Thrombosis/Thrombus (4440)

Event Date 03/11/2000

Event Type  Injury  

Event Description

O¿sullivan gj, semba cp, bittner ca, et al.Endovascular management of iliac vein compression (may-thurner) syndrome.Journal of vascular and interventional radiology.2000;11(7):823-836.Doi:10.1016/s1051-0443(07)61796-5 medtronic literature review found a report of patient complications in association with cragg-mcnamara infusion catheter.The purpose of this article was to evaluate the feasibility of endovascular techniques in treating venous outflow obstruction resulting from compression of the iliac vein by the iliac artery of the left lower extremity (may-thurner syndrome).There were 39 total patients included in the study (29 women, mean age 48.2 years).In patients treated with use of thrombolysis, a cragg-mc-namara catheter was used.Of the 20 chronic patients, 12 underwent thrombolysis and 8 did not.The article does not state any device deficiencies during use of the cragg-mcnamara infusion catheter.The following intra- or post-procedural outcomes were noted: - there was one technical failure with use of the device due to a small hematemesis at 1 hour, causing termination of thrombolysis.- major complications included two cases of acute rethrombosis (<(> <<)>24 hours) of the iliac segment, requiring reintervention.Both were re-treated with successful outcome.- minor complications included a small hematoma round the puncture site evident in four patients and a small hematemesis in one patient; two patients experienced minor anaphylactoid reactions to the urokinase infusion (transient rigor, chills) that was immediately responsive to intravenous administration of meperidine hydrochloride (50 mg) and diphenhydramine (50 mg).- one patient, who had a deep vein thrombosis (dvt) 8 years prior to endovascular intervention, reported a gradual worsening in symptoms.They already had severe valvular incompetence at the time of presentation.- there was said to be unfavorable experience with use of thrombolysis in patients with chronic symptoms.

Manufacturer Narrative

O¿sullivan gj, semba cp, bittner ca, et al.Endovascular management of iliac vein compression (may-thurner) syndrome.Journal of vascular and interventional radiology.2000;11(7):823-836.Doi:10.1016/s1051-0443(07)61796-5.If information is provided in the future, a supplemental report will be issued.

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 no medtronic devices were used.

• 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: 14174490
• MDR Text Key: 293726602
• Report Number: 2029214-2022-00691
• 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: 04/21/2022
• 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): Required Intervention; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female