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

Model Number APB-1-3-3D-ES

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that during the embolization process, the axium coil was automatically detached in the microcatheter.The detachment rod was completed and withdrawn, and the coil was pushed into the embolization site with a guide wire.It was noted the coil was not implanted in the intended location, but there was no medical or surgical intervention required.There was no damage to the pushwire, no friction during delivery, no detachment attempts made, no repositioning of the coil, no rotation of the pushwire, and no continuous flush used.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of neurovascular abnormalities not located in an eloquent region.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.

Manufacturer Narrative

A2.Patient's age updated (22 years).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

Medtronic received a report that during the embolization process, the axium coil was automatically detached in the microcatheter.The detachment rod was completed and withdrawn, and the coil was pushed into the embolization site with a guide wire.It was noted the coil was not implanted in the intended location, but there was no medical or surgical intervention required.There was no damage to the pushwire, no friction during delivery, no detachment attempts made, no repositioning of the coil, no rotation of the pushwire, and no continuous flush used.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of neurovascular abnormalities not located in an eloquent region.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.Additional information received indicated that the microcatheter and guidewire used in the event were non-medtronic products.

Manufacturer Narrative

H3.Product analysis: the axium prime pusher was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within a dispenser coil and within an introducer sheath.The opened axium prime outer carton and inner pouch were also returned.No damages or irregularities were found with the introducer sheath.The actuator interface was found securely attached to the coupler tube.The break indicator was found still intact.There were no evidence of detachment attempts at these locations.No damages or irregularities were found with the pusher.The coin was found still against the lumen stop.The shield coil was found intact.The implant coil was already detached and not returned for analysis.The retainer ring was found damaged (ovalized).The inner diameter of the retainer ring was measured to be 0.0050¿ at the widest axis, which is no longer within specification (specification: 0.00455¿ ± 0.00010¿).No other anomalies were observed.Based on the analysis performed, the customer report of ¿premature detachment" was confirmed.It is likely the damaged retainer ring caused the detach element to slip out and detach the implant coil, however, the cause of the damage could not be determined.Possible causes of damage to retainer ring are patient vessel tortuosity, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation or advancing/retracting the device against resistance.Customer reported no friction during delivery, no damage to pushwire, no detachment attempts were made, no repositioning of the coil, no rotation of the pushwire, vessel tortuosity as moderate, and no continuous flush was performed (which potentially could contribute towards resistance).There was no indication that the event is related to a potential manufacturing issue.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
• MDR Report Key: 11885681
• MDR Text Key: 252767635
• Report Number: 2029214-2021-00622
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536031821
• UDI-Public: 00847536031821
• Combination Product (y/n): N
• PMA/PMN Number: K151447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2021

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 Expiration Date: 10/30/2023
• Device Model Number: APB-1-3-3D-ES
• Device Catalogue Number: APB-1-3-3D-ES
• Device Lot Number: B109988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Manufacturer Received: 05/23/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 06/03/2021; 08/04/2021
• Supplement Dates FDA Received: 06/25/2021; 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR