MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM HELIX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number QC-2-4-HELIX

Device Problems Stretched (1601); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/26/2022

Event Type  Injury  

Event Description

Medtronic received a report that an axium prime coil was stuck in the sheath, and another axium coil used in the procedure prematurely detached.The patient was undergoing treatment for an unruptured, amorphous aneurysm located in the left cavernous sinus segment.The max diameter was 12.8mm, and the neck diameter was 8.9mm.The patient's blood flow was normal, and their vessel tortuosity was moderate.It was reported that resistance was very large and the coil could not be pushed into the microcatheter.After the coil was withdrawn and they tried to push in vitro, but it could not be pushed out.A replacement coil entered the microcatheter smoothly and embolized in place.During the procedure of embolization, when the surgeon made the re-recovery adjustment, the coil automatically stretched during the recovery process and could not be completely recovered into the microcatheter.Then, the surgeon decided to withdraw the microcatheter and the coil as a whole.During the overall withdrawal, it was found that the coil had been detached and remained in the intracavity of the tumor-bearing artery.Finally, the surgeon pressed the coil left outside the aneurysm with a stent.The surgeon believed that the automatic stretching caused the coil to remain in the blood vessel.The coil was not implanted at the intended location, and no additional medical/surgical intervention was required.The pushwire was not bent or broken.There had been no fric tion/difficulty during delivery of the coil that prematurely detached.The physician had repositioned the coil once, and no detachment attempts had been made.The physician did not rotate the delivery pusher.A continuous flush had been administered. the patient d id not experience any injury or symptoms.The devices were prepared according to the instructions for use (ifu).Ancillary devices include an 8f short sheath, 8f guiding catheter, echelon 10 microcatheter, and synchro.014 guidewire.

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 during preparation, the introducer sheath held vertically when the implant coil was pulled back inside during hydration.There were no issues that resulted in the damage that was found.

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.

Manufacturer Narrative

H3: that based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed.There were no reported issues preparing the axium prime implant coil prior to use per the instructions for use (ifu).Therefore, it is likely that the axium prime implant coil became damaged during preparation, or due to an improper hubbing technique (over tightening of the rhv).Regarding the damage (bends/kinks) found with the pushwire and the damage (stretched/broken) found with the axium prime implant coil damage can occur if the device is advanced against resistance or due to handling.However, the root cause for implant coil resistance could not be determined.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.

• Brand Name: AXIUM HELIX
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 15316459
• MDR Text Key: 298865404
• Report Number: 2029214-2022-01463
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536037281
• UDI-Public: 00847536037281
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081465
• 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,Followup
• Report Date: 11/08/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: QC-2-4-HELIX
• Device Catalogue Number: QC-2-4-HELIX
• Device Lot Number: 223667211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 08/31/2022; 10/12/2022
• Supplement Dates FDA Received: 09/20/2022; 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 70 KG