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

Model Number APB-4-12-HX-SS

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

This event was submitted from (b)(6), anvisa.Anvisa reports regard patient and healthcare provider in formation as confidential.Therefore, this information is not available for report or follow-up.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information received reporting that an axium coil detached prematurely.The event was not associated with a patient.No other information was known and the device was discarded.

• Brand Name: AXIUM PRIME BRPL HLX
• Type of Device: 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: 13011172
• MDR Text Key: 289258383
• Report Number: 2029214-2021-01618
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536008137
• UDI-Public: 00847536008137
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K081465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2023
• Device Model Number: APB-4-12-HX-SS
• Device Catalogue Number: APB-4-12-HX-SS
• Device Lot Number: 219982281
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/15/2021
• Date Device Manufactured: 05/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1