MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NV COIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number UNK-NV-COILS

Device Problem No Apparent Adverse Event (3189)

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

Event Date 09/15/2021

Event Type  malfunction  

Event Description

Medtronic received information that the concerto coil could not be detached with the instant detacher or by manually.The coil was retrieved and another coil was used to continue the procedure.It was noted the device was prepared and inspected per the instructions for use (ifu).There was no harm or injury to the patient.Additional information received reported that 28 detachment attempts were made with the instant detacher, and 7-8 were made with the manual method.Prior to the non-detachment there were no issues encountered, and no damage was observed to the pushwire after removal.

Manufacturer Narrative

This device was not the device initially reported in this event but was returned along with the complaint coil with no allegation or complaint information about the device.Analysis determined an additional reportable event involving this returned coil.Product analysis: as found condition- two coils were returned for analysis within in a shipping box, within a sealed plastic biohazard pouch; within an opened concerto outer carton; within an opened concerto inner pouch and within a plastic pouch.Visual inspection/damage location details: the actuator interface was found loose within the coupler tube, indicative of detachment attempt using an instant detacher.The pusher was found kinked between the positive load indicator and break indicator.The pusher was found broken distal to the break indicator, indicative of a manual detachment attempt at this location.The release wire was found separated from the proximal segment.The pusher was found kinked at ~35.1cm from the distal end.The coin was found retracted out of the lumen stop.The shield coil was found intact.The implant coil was found already detached and not returned for analysis.The retainer ring was found damaged.The coil was already detached.Testing/analysis ¿ the exposed release wire was retracted, and the coin was found to freely move within the pusher, which is expected.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was confirmed for the first coil.It is likely the cause of the non-detachment is the release wire became separated from the actuator interface causing the release wire to not retract during the detachment attempts.When the release wire was retracted during in-house analysis, the coin exited the lumen stop and the implant coil detached as expected by the detachment elements.The cause of the detachment from the actuator interface could not be determined.As the proximal segment of the pusher was not returned, the crimps could not be confirmed.The instant detacher used in the event was not returned.Therefore, any contribution of the instant detacher towards the non-detachment could not be determined.It is possible the issue could be related to a manufacturing issue, therefore, a device history review will be conducted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NV COIL
• 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: 13005965
• MDR Text Key: 285015059
• Report Number: 2029214-2021-01611
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-NV-COILS
• Device Catalogue Number: UNK-NV-COILS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• 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
• Patient Age: 64 YR
• Patient Sex: Female