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

Model Number	APB-2-8-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an axium coil that was stuck in the sheath.The patient was undergoing a coil embolization procedure to treat an unruptured saccular aneurysm of a basilar artery.The aneurysm max diameter was 4mm and the neck diameter was 3mm.Blood flow and vessel tortuosity were normal.It was reported that the axium coil and all accessory devices were prepared as indicated in the instructions for use (ifu).During d elivery, the coil could not be pushed in the microcatheter and was removed for safety.It was then found that the coil was stuck in the protective sheath.The coil was replaced to continue the procedure.There was no harm or injury to the patient.On 2021-08-18 (rep, for): additional information received indicated the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.
Additional Manufacturer Narrative
The axium prime implant coil was found to be damaged within the introducer sheath.The implant coil tip was found broken.The axium prime implant coil could not be pushed out from within the introducer sheath as resistance was encountered and was retracted out against resistance.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM PRIME BRPL HLX
• 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: 13938419
• Report Number: 2029214-2022-00508
• Device Sequence Number: 20478274
• Product Code: KRD
• UDI-Device Identifier: 00847536032200
• UDI-Public: 00847536032200
• 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
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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: 02/24/2024
• Device Model Number: APB-2-8-HX-ES
• Device Catalogue Number: APB-2-8-HX-ES
• Device Lot Number: B165949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2021
• 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: Male