MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-1-3-HX-ES
Medical Device Problem Codes	Break (1069); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
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 during the aneurysm embolization surgery, the surgeon delivered the coil into the aneurysm and discovered during the operation that the coil had stretched prematurely.There was coil separation/break/premature detachment.The coil was removed from the patient with overall slow withdrawal.There was no surgical or medicinal intervention required.There was no friction or difficulty during delivery.The physician repositioned the coil 2 times.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.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of an amorphous, ruptured ophthalmic artery aneurysm with a max diameter of 4 mm and a 2 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.
Event or Problem Description
Additional information was received that clarified that premature detachment occurred and that the coil was stretched.The cause of the event was not determined.There was no kink/damage observed on the pushiwre.
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.
Additional Manufacturer Narrative
H3: product analysis as found condition: the axium prime device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch, within an opened axium prime inner pouch, within a dispenser coil, and within an introducer sheath.No microcatheter was returned.Visual inspection/damage location details: the introducer sheath was found to be applied correctly and was found in good condition.The actuator interface was found securely attached to the coupler tube.The break indicator was found to be intact.No evidence of detachment attempts was found at these locations.The axium prime pusher was found bent at ~4.5cm from the proximal end.The shield coil was returned in good condition.The coin was found to be against the lumen stop.The implant coil was found to be attached to the detach element; however, the implant coil was found to be stretched within the introducer sheath.Polypropylene was found to be broken off the detachable element but still attached to the implant coil.The implant coil was found unbroken (tip still attached to implant).Testing/analysis: n/a conclusion: based on the device analysis and reported information, the customer report of ¿premature detachment¿ and ¿coil separation/break¿ could not be validated.No signs of any detachment attempt at the actuator interface, or the break indicator was found.In addition, no damages were found with the returned detachment subassemblies.The customer¿s report of ¿coil stretch¿ was able to be confirmed as the returned implant coil was found to be stretched within the introducer sheath, and still attached to the detach element.Possible causes for coil stretched are, but not limited to, lack of hydration before procedure, pushwire rotation, coil is not retracted in a one-to-one motion with the implant pusher during repositioning, and incompatible catheter.The report states that ¿there was no friction or difficulty during delivery.The physician repositioned the coil 2 times.The physician rotated the delivery pusher during the procedure.¿ it is possible the customer's report of repositioning and rotation of the pusher may have caused the implant coil to stretch, but this could not be verified.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 HLX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21918627
• Report Number: 9617601-2025-00426
• Device Sequence Number: 18413608
• Product Code: KRD
• UDI-Device Identifier: 00763000313807
• UDI-Public: 00763000313807
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 06/24/2025

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-1-3-HX-ES
• Device Catalogue Number: APB-1-3-HX-ES
• Device Lot Number: 227825498
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 06/13/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/15/2025; 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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: 37 YR
• Patient Sex: Female