MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM PRIME BARE PL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-1.5-2-3D-ES
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that an axium coil encountered resistance in the catheter and had stretched.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for a ruptured left posterior communicating artery aneurysm with a saccular morphology.Aneurysm dimensions: max diameter 2 mm, neck diameter 2 mm.The patient¿s vessel tortuosity was minimal and blood flow was normal.Access vessel was the femoral artery (7 mm).After the microcatheter was hydrated and plasticized normally, it reached the location of the lesion.After the axium coil was hydrated, it was filled.After a part of the spring coil entered the microcatheter, it could no longer enter after multiple adjustment at tempts.The coil could not be retracted and was stuck in the microcatheter.After many efforts outside the body, the coil had stretched when it was withdrawn, and the microcatheter could no longer be used.The catheter was flushed as indicated in the ifu.There were no patient symptoms or complications associated with this event.Additional information received that the procedure completed by replacing the microcatheter and spring coil.The cause of the resistance was not determined.The coil did not come out of the introducer sheath smoothly.
Additional Manufacturer Narrative
Product analysis # (b)(4).Equipment used: video inspection system (b)(6) ruler (b)(6) pin gauge sets (b)(6) camera (panasonic lumix dmc-zs5), in-house coil (model: apb-6-20-hx-ss lot: a142925) as found condition: the echelon-10 micro catheter and axium prime coil were returned for analysis within a shipping box and within two resealable plastic biohazard pouches.The axium prime coil was returned further within a dispenser coil and introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The axium prime pusher was found bent at ~56.8cm from the proximal end (figure e).The axium prime implant coil was found separated from the pusher at the detach element and found stretched.The distal implant coil was found stuck outside the introducer sheath (figure h).No flash or hub mold were found within the echelon-10 hub.No damages or irregularities were found with the echelon-10 hub, micro catheter body, or marker bands.The distal tip was found slightly crushed (figure k).Evidence of steam shaping was found on the distal micro catheter.Testing/analysis: the returned coil could not be used for resistance testing due to the damages.The axium prime implant coil tip od (outer diameter) was measured and found to be 0.0105¿ which is within specification (specification: 0.0108¿ +.0010/-.0020).The introducer sheath id (inner diameter) was measured and found to be 0.0175¿ (0.4445mm) which is within specification (specification: 0.46mm ±0.02mm).The echelon-10 total length was measured to be ~152.6cm and the useable length was measured to be ~145.1cm which is within specification (specification: total (ref) = 152cm, usable: 144.0cm ±1.5cm).The echelon-10 micro catheter was flushed, and water exited the distal end.An in-house coil was then used for resistance testing.The coil was inserted into the echelon-10 hub, through the micro catheter body, and out the distal end with no resistance encountered.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed as the damages found is consistent with resistance.The axium prime pusher was found bent, and the implant coil was found stretched/broken.Customer did not report any damages found during preparation per ifu, therefore, it is possible the implant coil became damaged during retraction of the implant coil following hydration or due to improper hubbing technique (over tightening of the rhv/sheath not fully seated within the hub) subsequently causing the implant coil to become stuck.Advancing the coil against resistance would result in damage to the implant and pusher.The damages would cause the subsequent reported ¿catheter resistance¿ and ¿coil resistance/stuck in catheter¿.The axium prime coil is compatible for use with the echelon-10 micro catheter as the echelon-10 has an inner diameter of 0.0165¿.There was no non-conformance to specifications found that would contribute towards the failures.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): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19264262
• Report Number: 9612164-2024-02169
• Device Sequence Number: 2569182
• Product Code: KRD
• UDI-Device Identifier: 00763000313647
• UDI-Public: 00763000313647
• 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
• Report Date (Section B): 05/07/2024

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: 227626125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2023
• 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: 67 YR
• Patient Sex: Female