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

Model Number APB-1-3-HX-ES

Device Problems Incomplete or Missing Packaging (2312); Material Deformation (2976)

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

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

See manufacturer report # 2029214-2021-01067 for another coil involved in this event.The actuator interface was found securely attached to the coupler tube.No evidence of detachment attempts using an instant detacher was found at this location.The break indicator was still intact.No evidence of manual detachment was found at this location.No damages or abnormalities were found at this location.The coin was found still within the lumen stop.The shield coil was found intact, and the detach element was found still attached to the pusher.The axium prime implant coil was broken from the detach element and not returned for analysis.The coil shell weld was found present.No other anomalies were found.Based on the customer report and device analysis, the customer report of ¿part missing/incomplete/loose¿ was confirmed for both devices.The implant coils were found to be broken from the detach element for both devices.The cause of the breaks could not be determined.There is an indication that the event is related to a potential manufacturing issue and a device history record review was conducted.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that with two coils "there wasn't coil body ," and two coils couldn't be pushed out of the protective sheath. the coils were replaced, and the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for a ruptured, amorphous aneurysm located in the ophthalmic artery segment.The max diameter was 4.21mm, and the neck diameter was 3.11mm.The patient's blood flow was normal, and the vessel tortuosity was moderate.Additional information received clarified that the statement "there wasn't coil body" meant that there were no coils on the pusher rod during hydration.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported only 2 of the 4 coils were returned for analysis.The other two coils could be returned.

• 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
• MDR Report Key: 12367893
• MDR Text Key: 268234023
• Report Number: 2029214-2021-01068
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536032101
• UDI-Public: 00847536032101
• Combination Product (y/n): N
• PMA/PMN Number: K151447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2023
• Device Model Number: APB-1-3-HX-ES
• Device Catalogue Number: APB-1-3-HX-ES
• Device Lot Number: B100700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR