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

Model Number APB-1.5-3-HX-ES

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

Patient Problem Foreign Body In Patient (2687)

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

A separate report will be submitted for the second coil reported in the event (model: apb-1.5-2-hx-es, lot: b193424) 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 information regarding 2 axium coils used in a procedure, one of which was stretched and detached prematurely and another that failed to detach.The patient was undergoing a coil embolization procedure to treat an internal carotid artery (ica) aneurysm.The aneurysm max diameter was 5mm and the neck diameter was 4mm.Vessel tortuosity was minimal.It was reported that all devices were prepared as indicated in the instructions for use (ifu).Continuous catheter flush was administered during the procedure.One coil detached prematurely and was stretched; the coil was removed with a solitaire ab (sab) stent retriever.There was been no friction or other difficulty noted during delivery.The physician did not attempt to reposition or detach the coil.Another coil used in the procedure could not be detached.5 attempts were made to manually detach the coil without success.The coil was replaced to continue the procedure.There was no harm or injury to the patient.

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 it had been attempted to detach the coil but it could not be detached, and that thread could not be pulled out.Another coil was automatically stretched in the body, and was pulled out of the body with a solitaire.

Manufacturer Narrative

Product analysis: as found condition (condition of returned device): two axium prime coils were returned for analysis within a shipping box and within a sealed tyvek biohazard pouch.Visual inspection/damage location details: due to the condition in which the axium prime coils were returned, it could not be determined which pli or product event each axium prime coil corresponds to.The axium prime coil was returned without introducer sheath.The actuator interface, positive load indicator, coupler tube, and break indicator were found to be intact.This is indicative mechanical method detachment was not attempted.The axium prime coil pushwire was found to be broken but retained by release wire at ~5.4cm, kinked at ~29.0cm, kinked at ~31.2cm and kinked at ~153.4cm from proximal end.The coin was found to be not against the lumen stop.The implant coil was 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 appeared to be damaged and appeared to have blood residue.The coin was unable to be measured accurately due to its damaged condition.The lumen stop was found to be visually damaged and was unable to be measured to be measured accurately.The retainer ring was found to be visually acceptable; however, was unable to be measured accurately due to appearing to be occluded.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.The customer reported no manual detachment of implant were attempted.Since the implant coil and included detach element were not returned for analysis, any contributing factors could not be determined.A possible cause for premature detachment is the coil not being retracted in a one-to-one motion with the implant pusher during repositioning.Based on the analysis performed, the axium prime coil was unable to be confirmed as a ¿non-detachment¿ as the pushwire was returned with the implant coil already detached.The likely cause for the non-detachment are the bends and kinks found on the pusher, causing the release wire to become stuck.The pusher was found bent/kinked.Possible causes for coil and pusher damage are, device was not hydrated, continuous flush was not administered during procedure, or damaged during shipment as the device was returned without its dispenser coil.Since the instant detacher was not returned, any contributing factors of the instant detacher to the non-detachment 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.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 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: 14398723
• MDR Text Key: 300140685
• Report Number: 2029214-2022-00818
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536032132
• UDI-Public: 00847536032132
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2022

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: 12/11/2023
• Device Model Number: APB-1.5-3-HX-ES
• Device Catalogue Number: APB-1.5-3-HX-ES
• Device Lot Number: B131640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 05/19/2022; 08/03/2022
• Supplement Dates FDA Received: 06/13/2022; 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male