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

Model Number 145-5091-150

Device Problem Difficult to Advance (2920)

Patient Problem Rupture (2208)

Event Date 08/23/2022

Event Type  Death  

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

The surgeon thought that our company's echelon had bad formability and retainability, there was a problem with this microcatheter.Our company's other microcatheters were able to maintain formability status, there was a delay in his treatment and the patient died because of this.The surgeon asked for a test report.It was charged, and the replaced microcatheter was also our company's echelon10.The surgeon believed that there was a problem with the scrapped microcatheter, which could not be formed and could not in place.The catheter was flushed as indicated in the instructions for use (ifu).The devices were prepared as indicated in the ifu.The patient was being treated for an aneurysm.The aneurysm ruptured and bled.Died in hospital.The access vessel was the femoral artery with a diameter of 7 mm.Ancillary devices: axium coils, synchro14 guidewire, navien microcatheter, 8f cordis sheath.

Manufacturer Narrative

Product analysis: as found condition: the echelon-10 micro catheter was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The echelon-10 outer carton label was also returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the echelon-10 hub, catheter body, marker bands or distal tip.The tip was found still pre-shaped at 45°.No evidence of steam shaping could be observed.Testing/analysis: the echelon-10 total length was measured to be 152.1cm, and the usable length was measured to be 144.1cm, which is within specification (specification: total (ref) = 152cm, usable: 144cm ±1.5cm).Conclusion: based on the device analysis and reported information, the customer¿s report of poor formability and retainability could not be confirmed.There was no evidence of steam shaping observed.Possible causes for poor steam shaping issues are incorrect heat sources (steam sources only), shaping mandrel not bent to a sufficient shape (slight over exaggeration of the desired shape), holding catheter not at appropriate distance from the steam source (1 inch), or not steam shaping for the correct time (~20 seconds).As the shaping mandrel and heat source used during the event was not returned for analysis, any contribution of the shaping mandrel/heat source towards the failure could not be assessed.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 the treatment location was the ophthalmic region.The vessel was not tortuous and there were no issues at the level of the common carotid artery.The surgeon thought that our microcatheter was not able to maintain the shape of the microcatheter, which delayed the filling treatment time of the coil.The patient was admitted to the hospital due to a ruptured aneurysm, not a ruptured aneurysm during the surgery, and the surgeon complained many times about using the product.Now, they are ready to convert out products to other companies' products.The surgery date was (b)(6) 2022 and the date of death was (b)(6) 2022.No autopsy was performed.The death is not thought to be related to medtronic device or therapy.It was only complained that the treatment time was delayed due to the molding problem of the microcatheter, and the admission diagnosis.

• Brand Name: ECHELON
• 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: 15644679
• MDR Text Key: 302157382
• Report Number: 2029214-2022-01768
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536006256
• UDI-Public: 00847536006256
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2024
• Device Model Number: 145-5091-150
• Device Catalogue Number: 145-5091-150
• Device Lot Number: B374856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• 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): Death
• Patient Age: 68 YR
• Patient Sex: Female