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

Model Number UNK-NV-FG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Pseudoaneurysm (2605)

Event Date 05/03/2023

Event Type  Injury  

Event Description

El naamani k, abbas r, sioutas gs, amllay a, tjoumakaris s, gooch mr, et al.A complication of the transradial approach: thyrocervical trunk pseudoaneurysm with hemothorax.Bjr case rep (2023) 10.1259/bjrcr.20220136.Medtronic review of the literature article found a case review of a patient who underwent a procedure for flow diversion treatment of a left carotid ophthalmic aneurysm via right radial access.The access sheath, guide catheter, and guidewire were non-medtronic devices which were used for the delivery of a phenom 27 microcatheter which was used to deliver the pipeline shield flow diverter stent which was successfully deployed across the aneurysm neck.Left carotid artery injections showed adequate placement of the pipeline.There was no reported device malfunction and it was noted that the procedure was uneventful.Ancillary devices: 088 ballast sheath, 0.038 terumo guidewire, & simmons 2 catheter.Post-operatively, the patient complaint of chest and abdominal pain that was worse when laying down and improved when sitting up.Cardia assessment was normal and the patient denied any difficulty breathing.Chest x-ray showed a 7cm right upper peri mediastinal opacity and abdominal and chest computed tomography (ct) and digital subtraction angiography (dsa) confirmed presence of a right thyrocervical trunk pseudoaneurysm.Thus the patient underwent an interventional endovascular procedure for onyx embolization of the pseudoaneurysm.Post-procedure angiogram showed complete occlusion of the pseudoaneurysm with no pooling of contrast.The patient's physical exams and vitals remained normal and stable and the patient was discharged home the following day with orders for continued dual antiplatelet regimen of plavix and aspirin.

Manufacturer Narrative

Associated with mdr #: 2029214-2023-01419.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: PHENOM
• 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: 17565455
• MDR Text Key: 321354322
• Report Number: 2029214-2023-01420
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151638
• 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
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-FG
• Device Catalogue Number: UNK-NV-FG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• 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): Required Intervention