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 Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Renal Failure (2041); Embolism/Embolus (4438); Swelling/ Edema (4577)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Poursina o, elizondo-adamchik h, montero-baker m, pallister z, mills j, chung j.Safety and efficacy of an endovascular-first approach to acute limb ischemia.Journal of vascular surgery 2020; 1:9.Doi: 10.1016/j.Jvs.2020.10.002.The purpose of this article was to describe the current outcomes for an endovascular first approach to acute limb ischemia (ali).Catheter directed thrombolysis (cdt) was delivered using a multi-side hole catheter (cragg mcnamara).An endovascular-first approach for all 60 patients resulted in a technical success rate of 97% (n = 58).Other complications included myocardial infarction in one patient (1.7%), atrial fibrillation in six (10%), and nonhemorrhagic stroke in two patients (3.3%).Acute kidney injury occurred in nine patients (15%), all of which had resolved with conservative management.The perioperative complications included access site hematoma in four patients (6.7%), all of which resolved with conservative management without postoperative transfusion; distal embolism in one patient (1.7%), managed with graft thrombectomy of the popliteal and peroneal arteries; myocardial infarction (mi) in one patient (1.7%), atrial fibrillation in six patients (10%), and nonhemorrhagic stroke in two patients (3.3%).No cases of intracranial hemorrhage or gastrointestinal bleeding occurred.At the last follow-up, 12 patients had died (20%), of the 60 patients, the average age was 65 years, there were 21 women and 39 men.The article does not state any technical issues during use of the mcnamara catheter.The following intra- or post-procedural outcomes were noted: 1.Death 12 (20%) 2.Acute renal failure 9 (15.0) 3.Atrial fibrillation 6 (10.0) 4.Fasciotomy 5 (8.0) 5.Minor hemorrhage 4 (6.7) 6.Ischemic stroke 2 (3.3) 7.Myocardial infarction 1 (1.7) 8.Embolism 1 (1.7).

Manufacturer Narrative

Poursina o, elizondo-adamchik h, montero-baker m, pallister z, mills j, chung j.Safety and efficacy of an endovascular-first approach to acute limb ischemia.Journal of vascular surgery 2020; 1:9.Doi: 10.1016/j.Jvs.2020.10.002.Pt age is the average age of the patients in the article.Pt sex is the majority of the patients in the 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.

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 medtronic products were not 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: 14314005
• MDR Text Key: 294390667
• Report Number: 2029214-2022-00792
• 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: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 07/21/2022
• Supplement Dates FDA Received: 08/10/2022
• 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
• Patient Age: 65 YR
• Patient Sex: Male