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

Model Number	APB-5-15-HX-SS
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the axium prime coil stretched upon deployment and detached while half of it was still in the microcatheter.The patient was undergoing treatment for an unruptured aneurysm located in the basilar tip.It was reported that the coil stretched upon deployment.The doctor started to withdraw the microcatheter and noticed the coil had s tretched.It detached half in the aneurysm and half in the microcatheter.Once it was detached within the catheter, the doctor had to push it out and several loops fell out of the aneurysm into the pca.The doctor had to put a second stent within the pca to trap the coils between the initial stent and the bail out stent.There had been no friction/difficulty during testing or delivery, and a continuous flush had been used.The physician did not reposition the coil during the procedure. the patient did not experience any injury.The devices were prepared according to the instructions for use (ifu).

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11606763
• Report Number: 2029214-2021-00386
• Device Sequence Number: 16964147
• Product Code: KRD
• UDI-Device Identifier: 00847536008229
• UDI-Public: 00847536008229
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2021

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: 06/24/2023
• Device Model Number: APB-5-15-HX-SS
• Device Catalogue Number: APB-5-15-HX-SS
• Device Lot Number: B045437
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1