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

Model Number	APB-2-3-HX-ES
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The axium prime coil was returned for analysis.The axium prime pusher was returned without its introducer sheath.Therefore, any contributing factors from the introducer sheath could not be assessed.No bends or kinks were found with the axium prime pushwire.The axium prime implant coil was found to be broken.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ could not be confirmed and the cause could not be determined.The axium prime implant coil was broken.There was no non-conformance to specifications identified that led to the reported issue.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 delivered to the microcatheter and the coil was found to be stretched under the image.The coil was replaced and the operation was completed.There were no patient symptoms or complications associated with this event.The device was prepared as indicated in the ifu.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm in the m1 segment of the right middle cerebral artery with a max diameter of 3mm and a 1mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.Additional information was received indicating there were no damages to the product.

• 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: 13434946
• Report Number: 2029214-2022-00146
• Device Sequence Number: 2084606
• Product Code: KRD
• UDI-Device Identifier: 00847536032170
• UDI-Public: 00847536032170
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/02/2022

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: 05/20/2023
• Device Model Number: APB-2-3-HX-ES
• Device Catalogue Number: APB-2-3-HX-ES
• Device Lot Number: B027950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2020
• 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: 61 YR
• Patient Sex: Female