MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CRAGG-MCNAMARA; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-CRAGG-MC

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2010

Event Type  Injury  

Event Description

Midulla, m., martinelli, t., goyault, g., lions, c., abboud, g., koussa, m., mounier-véhier, c., amp; beregi, j.-p.(2010).T-stenting with small protrusion technique (tap-stenting) for stenosed aortoiliac bifurcations with small abdominal aortas: an alternative to the classic kissing stents technique.Journal of endovascular therapy, 17(5), 642¿651.Https://doi.Org/10.1583/10-3052.1 summary: to report the feasibility and midterm results of aortic bifurcation reconstruction in patients with small abdominal aortas using commercially available stents applied in a modified t-stenting technique adapted from coronary angioplasty.2022-apr-06 lit (hcp, sdy, for): medtronic received a report that the patient with an in-stent thrombosis after previous iliac stenting received intra-arterial fibrinolysis with a bolus injection of 100,000 iu of urokinase followed by a 4000-iu/h infusion over 3 hours.No predilation was performed.During the hospital stay, antiplatelet therapy was continued with clopidogrel (75 mg/d).Only the patient with thrombosis was given 24 hours of intravenous heparin.

Manufacturer Narrative

Midulla, m., martinelli, t., goyault, g., lions, c., abboud, g., koussa, m., mounier-véhier, c., <(>&<)>amp; beregi, j.-p.(2010).T-stenting with small protrusion technique (tap-stenting) for stenosed aortoiliac bifurcations with small abdominal aortas: an alternative to the classic kissing stents technique.Journal of endovascular therapy, 17(5), 642¿651.Https://doi.Org/10.1583/10-3052.1.Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.The date is year valid.Event: it was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.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 was not the manufacturer or the products indicated in this study.

• 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: 14161593
• MDR Text Key: 289676535
• Report Number: 2029214-2022-00670
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 05/23/2022

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?: No
• Date Manufacturer Received: 05/12/2022
• 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): Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male