MAUDE Adverse Event Report: PERFUSION SYSTEMS AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-2.5-4-3D-ES
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that an axium coil had early detachment and damage.The patient was being treated for an unruptured saccular aneurysm in the left middle cerebral artery (mca).The aneurysm maximum diameter is 3mm and neck diameter is 3mm.Vessel tortuosity was severe.  the devices were prepared according to the indication for use (ifu). after inserting this product, it was tried to pull once at the remaining 1cm, but there was no resistance and the coil did not move due to unraveling or early detachment.Confirmed by conbeam ct, and it was determined to be early detachment.As the coil deviated outside the aneurysm, an atlas stent was used in an emergency to restrain the coil.The coil was relocated once.When it was tried to relocate and pull, it had early detachment at that time.There was no resistance during delivery and they did not try to detach the coil.During the procedure, the flush was performed without interruption.No symptoms were reported.Ancillary devices: atlas stent, catheter.
Additional Manufacturer Narrative
H6: fdr updated to c0706.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.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.
Additional Manufacturer Narrative
See a1, h1, and g4 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.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): an axium prime coil was returned for analysis within a shipping box; within a resealable biohazard bag and within a resealable bag.Visual inspection/damage location details: the axium prime implant coil was returned already detached.The axium prime pushwire assembly was returned without introducer sheath.The pushwire was found to kinked at ~181.4cm from proximal end.The coin was found to be still against the lumen stop.The implant coil was found to be already detached and not returned.No other anomalies were observed.Testing/analysis (including sem reports): under the microscope, the outer jacket was then removed to gain access to the coin.The coin was found to be broken.The coin was unable to be measured due to its damaged condition.The lumen stop was found to be visually acceptable; however, the distal tip of coin was found to be broken within lumen stop.The retainer ring was found to be visually acceptable; however, was unable to be accurately measured.Conclusion: based on the analysis performed, the customers report of ¿premature detachment¿ was confirmed as the axium prime was returned with the implant already detached.However, the cause could not be determined.Since the included detach element was not returned for analysis, any contributing factors could not be determined.Possible causes for premature detachment are tortuous anatomy, pusher rotation and the coil not being retracted in a one-to-one motion with the implant pusher during repositioning.Based on the analysis performed, the customers report of ¿coil kink/damage¿ was confirmed as the axium prime was found to be kinked.However, the root cause could not be determined.Possible causes for ¿kink/damage¿ are patient vessel tortuosity or advancing device against resistance.The customer reported patient vessel tortuosity as severe.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
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12338506
• Report Number: 9612164-2021-03188
• Device Sequence Number: 11897796
• Product Code: KRD
• UDI-Device Identifier: 00847536021204
• UDI-Public: 00847536021204
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2023
• Device Model Number: APB-2.5-4-3D-ES
• Device Catalogue Number: APB-2.5-4-3D-ES
• Device Lot Number: 221070134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 09/14/2021; 10/29/2021; 12/10/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 10/05/2021; 11/15/2021; 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female