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

Model Number	APB-1.5-2-3D-ES
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
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
Medtronic received a report that the physician waned to remove the (last) coil, because it was not optimal in place.While pulling the pusher wire, the coil didn¿t move, so it was already detached without the detach mechanism.There was coil premature detachment.The coil remained in the patient and was implanted at the intended location.There was no surgical or medicinal intervention required.The pushwire was not bent or broken.There was no y friction or difficulty during delivery.The physician repositioned the coil one time.The physician did not attempt to detach the coil.  the physician rotated the delivery pusher during procedure.The continuous flush was administered during the procedure.The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, unruptured internal carotid artery (ica) aneurysm with a max diameter of 6mm and a 5mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.Ancillary devices include a sl-10 str  microcatheter.
Additional Manufacturer Narrative
Product analysis: as found condition: the axium prime pusher was returned for within a shipping box; within a sealed plastic biohazard pouch; within an opened axium prime outer carton and within an unsealed plastic pouch.The sl-10 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.No damages or irregularities were found with the pusher.The coin was found still against the lumen stop.The coin was found undamaged.The shield coil was found undamaged.The implant coil was already detached and not returned for analysis.Customer reported the implant coil remained within the patient.The retainer ring was found undamaged.Testing/analysis: the inner diameter of the retainer ring was measured to be 0.0051¿, which was within specification (specification: 0.00455¿ ± 0.00010¿).The release wire was extending out of the pusher ~0.0039¿ which is within specification (specification: 0.002¿ - 0.005¿).The coin was measured to be ~0.083mm @ 0.063mm, ~0.089mm @ 0.0127mm, and ~0.091mm @ 0.0275mm; which is within specification (specification: 0.063mm ¿ 0.089mm @ 0.063mm; 0.075mm ¿ 0.0105mm @ 0.0127mm; and 0.086mm ¿ 0.0108 @ 0.0275mm) no other anomalies were observed.Conclusion: based on the analysis performed, the customer report of ¿premature detachment" was confirmed; however, the cause could not be determined.Possible causes are tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pusher rotation, user advances the coil against resistance, and detachment ball outer diameter below specification/damaged.Customer reported vessel tortuosity as moderate, no resistance was encountered, repositioning was performed once, continuous flush was administered, and the devices were prepared per ifu.There were no irregularities or non-conformance to specifications found that would contribute towards the premature detachment.The customer report of ¿difficult placement/positioning¿ typically could not be confirmed through device analysis.Possible causes are patient vessel tortuosity, catheter tip under stress, or catheter kickback.As the sl-10 micro catheter and implant coil (including the detach element) were not returned for analysis, any contribution of the micro catheter, implant coil and detach element to the premature detachment and difficult placement/positioning 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: 19286514
• Report Number: 9612164-2024-02255
• Device Sequence Number: 8474100
• Product Code: KRD
• UDI-Device Identifier: 00763000313647
• UDI-Public: 00763000313647
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 07/30/2024

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-1.5-2-3D-ES
• Device Catalogue Number: APB-1.5-2-3D-ES
• Device Lot Number: 227825911
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2023
• 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
• Patient Age: 55 YR
• Patient Sex: Female