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

Model Number APB-2-6-HX-ES

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2021

Event Type  Injury  

Event Description

Medtronic received a report that the axium prime coil prematurely detached and remained in the patient at an unintended location.The patient was undergoing treatment for an unruptured, amorphous aneurysm located in the posterior communicating artery.The max diameter was 3.42mm, and the neck diameter was 2.83mm.The patient's blood flow and vessel tortuosity were normal.It was reported that no additional medical or surgical interventions were required.The microcatheter was used for post treatment.There had been no friction or difficulty during delivery.The physician did not reposition the coil, and no detachment attempts were made.The physician did rotate the delivery wire during the procedure, and a continuous flush was administered.The pushwire was not bend or broken. the coil was replaced, and the patient did not experience any injury or symptoms.The devices were prepared according to the instructions for use (ifu).

Manufacturer Narrative

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

Manufacturer Narrative

H3.Product analysis: as found condition: the axium prime coil was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within a dispenser coil.The opened axium prime outer carton was also returned.The unknown micro catheter used during the event was not returned for analysis.Visual inspection/damage location details: 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.The distal axium prime pusher was found kinked.The coin was found still against the lumen stop.The coin was found undamaged.The shield coil was found intact and unstretched.The implant coil was found still attached to the pusher.The implant coil was found stretched with the polypropylene filament broken.No damages or irregularities were found with the implant coil tip.Conclusion: based on the analysis performed, the customer report of ¿premature detachment" was not confirmed.Customer reported a portion of the implant coil remained in the patient which is not confirmed as the entire length of the implant coil was found still attached to the pusher.However, the implant coil was found stretched.Possible causes for coil stretch are lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances the coil against resistance or incompatible catheter.The distal pusher was found kinked, indicative of advancing against resistance.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the coil stretching and pusher kinking could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.There was no indication that the event is related to a potential manufacturing issue.H6.Codes were updated based on analysis results.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 PRIME BRPL HLX
• 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: 12756400
• MDR Text Key: 285343815
• Report Number: 2029214-2021-01403
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00763000313890
• UDI-Public: 00763000313890
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151447
• 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: 12/22/2021

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: 05/23/2024
• Device Model Number: APB-2-6-HX-ES
• Device Catalogue Number: APB-2-6-HX-ES
• Device Lot Number: 222290417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other