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

Model Number	APB-4-12-3D-SS
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): the axium prime implant coil was returned for analysis within a shipping box; within a smaller shipping box; within an open axium prime coil carton; within an open axium prime inner pouch, and within a sealed plastic bag.Visual inspection/damage location details: the axium prime implant coil was returned within the introducer sheath.The introducer sheath was found to be applied correctly with the wavelock towards the proximal end.The axium prime pushwire was found to be bent at 4.5cm and bent at 43.5cm from the proximal end.The axium prime implant coil was found to be damaged within the introducer sheath.In addition, the implant coil was found to have broken off from the pushwire from the coil shell weld.In addition, the implant coil polypropylene filament broke off from the detach element.The detach element remained still attached to the pushwire.The introducer sheath was found to have damaged at 10.5cm from the distal end.The implant coil was not able to be pushed out from within the introducer sheath as resistance was encountered.No other anomalies were found.Testing/analysis (including sem reports): the axium prime implant coil tip od (outer diameter) was unable to be determined as it could not be removed from within the introducer sheath for testing.The sheath id (inner diameter) was measured to be at 0.019¿ (specification 0.47¿ +0.03¿ / - 0.00¿) which is within specification.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed.There were no reported issues preparing the axium prime implant coil prior to use per the instructions for use (ifu).Therefore, it is likely that the implant coil became damaged during preparation or due to an improper hubbing technique (over tightening of the rhv) causing resistance within the introducer sheath.However, the root cause for the resistance could not be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information reporting that an axium coil had a defect observed prior to use with a patient.It was noted the device was prepared according to the instructions for use (ifu).Medtronic received information regarding the axium coil having a defect observed which led to the device not being able to be passed through the catheter sheath.

• 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: 14231925
• Report Number: 2029214-2022-00731
• Device Sequence Number: 4378995
• Product Code: KRD
• UDI-Device Identifier: 00847536032019
• UDI-Public: 00847536032019
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K081465
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

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: 12/27/2022
• Device Model Number: APB-4-12-3D-SS
• Device Catalogue Number: APB-4-12-3D-SS
• Device Lot Number: A952664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 04/28/2022
• Date Device Manufactured: 12/28/2019
• 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 Sex: Unknown