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

Model Number	APB-3-10-HX-ES
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
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 coil was detached using an instant detacher.As the pushwire was pulled back, the physician noticed something thin visible on the screen still attached to the coil.At the microcatheter hub, a hair like filament was present.The filament could not be pulled as it was still connected to the coil.As the left jugular vein was occluded, the physician pushed out the filament in the vein and it was left implanted.There was no future plan or intention to remove the filament from the patient body.The physician acknowledged they put some force on the coil while repositioning which may have caused the coil stretch, but did not think the filament was a stretched coil.Once the filament was stationed in the patient' vein, the microcatheter was repositioned, and the procedure was completed.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of an unspecified neurovascular abnormality of the left sigmoid sinus with normal vessel tortuosity.Ancillary devices include a headway duo.

• 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
• MDR Report Key: 12332843
• Report Number: 2029214-2021-01022
• Device Sequence Number: 4441682
• Product Code: KRD
• UDI-Device Identifier: 00763000313982
• UDI-Public: 00763000313982
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2024
• Device Model Number: APB-3-10-HX-ES
• Device Catalogue Number: APB-3-10-HX-ES
• Device Lot Number: 221522087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other