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

Model Number	APB-1.5-3-3D-ES
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding two axium coils that had resistance during delivery in the echelon 10 microcatheter and one of the coils detached prematurely.The patient was undergoing a coil embolization procedure to treat a ruptured saccular anterior communicating artery aneurysm.The aneurysm max diameter was 3mm and the neck diameter was 1.3mm.Blood flow and vessel tortuosity were normal.  it was reported that devices were prepared and catheter was flushed continuously per the instructions for use (ifu).The echelon 10 microcatheter was delivered in place.The first coil was an axium coil model qc-3-6-3d which was hydrated and introduced into the catheter.There was resistance/friction during delivery of the coil int he catheter, however, the coil was successfully delivered and deployed.The second coil was was an axium coil model qc-2-4-helix-cn.When advancing to the middle of the echelon microcatheter, there was significant resistance and the coil could not be delivered despite multiple attempts.The coil was removed and replaced with a different axium coil, model: apb-1.5-3-3d-es.However, this coil also had resistance in the middle-distal echelon microcatheter and the coil detached prematurely within the catheter so both the coil and catheter were removed and replaced to complete the procedure successfully.Regarding the coil that detached in the catheter, it was noted that the surgeon had not repositioned or attempted to detach the coil and the delivery pusher was not rotated.There was no harm or injury to the patient.
Additional Manufacturer Narrative
Continuation of d10: product id 190-5091-150 (lot: 0228061964); product type: ; implant date n/a; explant date n/a.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received that the coils came out of the introducer sheath smoothly.There was no kink/damage to the catheter observed after removal.Regarding the prematurely detached coil, there was no kink/damage observed on the pushwire.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): two axium implant coils and an ecehlon-10 micro catheter were returned for analysis within a shipping box and two separately sealed biohazard pouches and the axium coils within an addition resealable biohazard pouch.The axium implant coils were returned within their introducer sheaths.Visual inspection/damage location details: the actuator interface, positive load indicator and coupler tube 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 break indicator.The coin was found to be not against the lumen stop.The implant coil was already detached and returned.The implant coil was found to be stretched and damaged.No other anomalies were observed.Testing/analysis (including sem reports): the axium coils could not be used for resistance testing with the returned echelon-10 micro catheter due to their damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed.Possible contributing factors to ¿coil resistance/stuck in catheter¿ include 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 ¿catheter resistance¿ could not be confirmed, and the root cause could not be determined.In addition, an in-house guidewire was able to pass through and exit the distal tip of the returned echelon-10 micro catheter without issue.It is possible the damages (flattened) found with the returned echelon-10 micro catheter may have contributed to the reported resistance.Possible contributing factors to ¿catheter resistance¿ include failure to prepare the ancillary devices prior to use, and insufficient catheter flush.Based on the analysis performed, the customers report of ¿premature detachment¿ was confirmed as the axium coil was returned with the implant already detached; however, the root cause could not be determined.It is likely the premature detachment was due to the p ushwire break at break indicator causing the release wire to be pulled back and releasing the implant coil.It is possible the damage (break/bent) to the pushwire occurred upon attempting to remove the product from catheter against resistance.The customer reported resistance.The root cause could not be determined.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: AXIUM PRIME BARE PL 3D
• Common Device Name: 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20417563
• Report Number: 9617601-2024-00235
• Device Sequence Number: 12838106
• Product Code: KRD
• UDI-Device Identifier: 00763000313654
• UDI-Public: 00763000313654
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2024

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
• Operator of Device: Health Professional
• Device Model Number: APB-1.5-3-3D-ES
• Device Catalogue Number: APB-1.5-3-3D-ES
• Device Lot Number: 228012931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: Not provided; 11/21/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/06/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 58 YR
• Patient Sex: Female