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

Model Number	APB-1-2-3D-ES
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a coil encountered resistance in the middle section of the catheter and another coil had premature detachment.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm of the left anterior communicating artery with a max diameter of 4mm and a 2mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was severe.It was reported that during the filling process, apb-3-8-hx was used and greater resistance was found during the delivery process.The catheter was not damaged and it was unknown if the coil was damaged.After replacing with the same model, the spring coil successfully delivered the embolization, and the last coil was selected apb-1-2-3d.After several adjustments, the surgeon discovered that the spring coil wiredrawn.Apb-1-2-3d was removed from the patient by retracting the pusher.There was no surgical or medicinal intervention required.The pushwire was not bent or broken.The physician repositioned the coil 3 times.The physician did not attempt to detach the coil.The physician rotated the delivery pusher during the procedure.Continuous flush was administered during the procedure.The reported devices and any accessory devices were prepared as indicated in the instructions for use (ifu).It was unknown if there were any patient symptoms or complications associated with this event.
Additional Manufacturer Narrative
Continuation of d10: product id apb-3-8-hx-es (lot: 226870620); 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.
Event or Problem Description
Additional information received that the procedure was completed after discovering the prematurely detached coil by taking out the spring coil, implanted the spring coil in turn.The coil came out of the introducer sheath smoothly.The catheter was not a medtronic product.
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 procedure was completed after discovering the prematurely detached coil by taking out the spring coil, implanted the spring coil in turn.The coil came out of the introducer sheath smoothly.The catheter was not a medtronic product.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): the axium prime coil was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within an opened axium prime coil inner pouch and within a dispenser track.The micro catheter used in the event was not returned.The axium prime coil was returned within an introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The actuator interface was securely attached to the coupler tube.No evidence of mechanical detachment using an instant detacher was found.The break indicator was found intact.This is indicative that a manual detachment was not performed.No bends or kinks were found with the axium prime coil pushwire.The shield coil was found intact with the implant coil still attached.The implant coil appeared to be stretched and damaged with the polypropylene filament intact.The axium prime coil was pushed out from introducer sheath for further analysis.The implant coil was found to be stretched and damaged.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the analysis performed, the customers report of ¿premature detachment¿ was unable to be confirmed as the axium prime coil was still attached.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 BRPL 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: 19604200
• Report Number: 9612164-2024-02969
• Device Sequence Number: 7392469
• Product Code: KRD
• UDI-Device Identifier: 00847536021112
• UDI-Public: 00847536021112
• 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): 09/04/2024

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-1-2-3D-ES
• Device Catalogue Number: APB-1-2-3D-ES
• Device Lot Number: 227568604
• 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: 06/23/2024
• Supplement Date Received by Manufacturer: Not provided; 08/21/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/22/2024; 09/04/2024
• Date Device Manufactured: 10/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 53 YR
• Patient Sex: Female