MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number APB-6-15-3D-SS

Device Problems Stretched (1601); Detachment of Device or Device Component (2907); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/31/2022

Event Type  Injury  

Event Description

Medtronic received a report that the axium prime coil prematurely detached and was stretched.The patient was undergoing treatment for an unruptured, amorphous aneurysm located in the anterior communicating artery.The max diameter was 5.8mm, and the neck diameter was 4.6mm.The patient's blood flow was normal and their vessel tortuosity was moderate.It was reported that coil was accidentally detached during filling.Part of the coil was in the aneurysm, and the rest was in the parent artery.When the surgeon continued to push, it stretched.The surgeon used three stents to press the coil body against the vessel wall.The coil was not implanted at the intended location.No additional medical/surgical intervention was required.It was noted that the pushwire was bent or broken, which was not on purpose, and there had been friction/difficulty during delivery.The physician did not reposition the coil, no detachment attempts had been made, and the pusher was not rotated.A continuous flush had been administered. the patient did not experience any injury or symptoms.The devices were prepared according to the instructions for use (ifu).

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

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 the resistance was in the proximal part of the catheter.The catheter used in the event was an echelon 10.The coil had pushed out the introducer smoothly, and the cause of the event was unknown.

Manufacturer Narrative

Product analysis: as found condition (condition of returned device): an axium prime coil was returned for analysis within a shipping box and within sealed biohazard pouch.The echelon micro catheter used during the event was not returned.Visual inspection/damage location details: the model and lot numbers for the echelon micro catheter were not provided; therefore, compatibility could not be assessed.The axium prime coil was returned without the introducer sheath.The actuator interface was securely attached to the coupler tube.No evidence of mechanical detachment using an instant detacher was found at this location.The break indicator was found intact.This is indicative that a manual detachment was not performed.The pushwire was found to be kinked at ~38.1cm, at 40.4cm, and bent at ~65.0cm from proximal end.The coin was found still against the lumen stop.The shield coil was found to be intact.The implant coil appeared to have been broken and not returned.No other anomalies were observed.Testing/analysis (including sem reports): n/a.Conclusion: based on the analysis performed, the customers report of ¿premature detachment¿ was unable to be confirmed as the pushwire was found to be broken not detached.There was no malfunction of the device or non-conformance to specification identified that led to a premature detachment.Based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ was unable to be confirmed as the implant coil was not returned.The root cause could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed as the axium prime coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Possible contributing factors to ¿coil resistance/stuck in catheter¿ include the use of an incompatible device for delivery, failure to hydrate the axium implant coil prior to use, and lack of continuous flush during delivery.Based on the device analysis and reported information, the customer¿s report of ¿pusher kink¿ was confirmed.Pushwire damage can occur if the user advances the device against resistance.The customer reported resistance in catheter during event.It is likely the resistance in catheter contributed to the ¿pusher kink¿.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.

Manufacturer Narrative

H3: product analysis of apb-6-15-3d-ss, lot# a920180 visual inspection/damage location details: the model and lot numbers for the echelon micro catheter were not provided; therefore, compatibility could not be assessed.The axium prime coil was returned without the introducer sheath.The actuator interface was securely attached to the coupler tube.No evidence of mechanical detachment using an instant detacher was found at this location.The break indicator was found intact.This is indicative that a manual detachment was not performed.The pushwire was found to be kinked at ~38.1cm, at 40.4cm, and bent at ~65.0cm from proximal end.The coin was found still against the lumen stop.The shield coil was found to be intact.The detach element appears to have been broken and the implant coil appeared to have been detached and not returned.No other anomalies were observed.Conclusion: based on the analysis performed, the customers report of ¿premature detachment¿ was unable to be confirmed as the detach element was found to be broken not detached.There was no malfunction of the device or non-conformance to specification identified that led to a premature detachment.Based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ was unable to be confirmed as the implant coil was not returned.The root cause could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed as the axium prime coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Possible contributing factors to ¿coil resistance/stuck in catheter¿ include the use of an incompatible device for delivery, failure to hydrate the axium implant coil prior to use, and lack of continuous flush during delivery.Based on the device analysis and reported information, the customer¿s report of ¿pusher kink¿ was confirmed.Pushwire damage can occur if the user advances the device against resistance.The customer reported resistance in catheter during event.It is likely the resistance in catheter contributed to the ¿pusher kink¿.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: AXIUM PRIME BRPL 3D
• 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: 15349721
• MDR Text Key: 299184158
• Report Number: 2029214-2022-01489
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536032064
• UDI-Public: 00847536032064
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2022
• Device Model Number: APB-6-15-3D-SS
• Device Catalogue Number: APB-6-15-3D-SS
• Device Lot Number: A920180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 09/05/2022; 10/20/2022; 03/15/2023
• Supplement Dates FDA Received: 10/03/2022; 11/15/2022; 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2019
• 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): Other
• Patient Age: 51 YR
• Patient Sex: Female