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

Model Number	APB-3-4-3D-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	11/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: as found condition: the axium prime coil was returned for analysis within a shipping box, within a plastic bio-pouch, and within a dispenser coil.Visual inspection/damage location details: axium prime pusher was found bent at 154.0cm from the proximal end.The shield coil was found in good condition.The release wire coin was found against the lumen stop.The implant coil was found not attached to the pusher.The implant coil was found to have broken off from the pusher from the coil shell weld.In addition, the implant coil polypropylene filament broke off from the detach element.The implant coil was not returned with the pusher.Testing/analysis: none.Conclusion: based on the device analysis and reported information, the customer¿s ¿coil resistance/stuck in catheter¿ and ¿coil stretch¿ reports were confirmed; however, the root cause could not be determined.Advancing the axium prime coil against resistance would result in damage to the pusher and implant coil subsequently causing the implant coil to stretch and break off from the pusher.Possible contributing factors to ¿coil resistance¿ include using an incompatible device for delivery, tortuous anatomy, failure to maintain a continuous flush or failure to hydrate the axium prime coil before use.The patient¿s vessel tortuosity was ¿moderate¿, a continuous saline flush was used, and the axium prime coil was prepared prior to use.The echelon-10 micro catheter used in the event was not returned.Therefore, an analysis could not be performed and conformance to specification could not be assessed.The echelon-10 micro catheter was found compatible for use with the axium prime coil.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017¿.Per the axium prime coil ifu (instructions for use), axium prime coils should only be delivered through a microcatheter with a minimum inside diameter of 0.0165¿¿0.017¿ with two marker bands.Therefore, the echelon-10 micro catheter was found to be compatible for use with the axium prime coil.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the coil had resistance and was stretched.The patient was undergoing surgery for treatment of a sa ccular, ruptured aneurysm in the basilar artery with a max diameter of 4mm and a 3mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.It was reported that during interventional embolization of the aneurysm, after echelon 10 was in place, the surgeon chose apb-3-4-3d-es detachable coil for embolization.When the detachable coil was delivered in the microcatheter, there was obvious resistance.Based on the safety of the operation, the surgeon pulled the coil out of the body and found that the coil had been stretched.A new coil was replaced, and the operation proceeded smoothly.The operator believed that it was a product quality problem and requested it to be returned.The continuous flush was administered during the procedure.No patient symptoms or further complications were reported as a result of this event.The reported device and any accessory devices were prepared as indicated in the ifu.Ancillary devices include a echelon 10 microcatheter.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13447182
• Report Number: 2029214-2022-00155
• Device Sequence Number: 5437078
• Product Code: KRD
• UDI-Device Identifier: 00847536031920
• UDI-Public: 00847536031920
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2022

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 Expiration Date: 07/20/2023
• Device Model Number: APB-3-4-3D-ES
• Device Catalogue Number: APB-3-4-3D-ES
• Device Lot Number: B056983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2020
• 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
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female