MAUDE Adverse Event Report: MICROVENTION INC. ERIC 6; THROMBUS RETRIEVER CATHETER

Model Number ER176044

Device Problem Break (1069)

Patient Problems Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The alleged product issue/event as described could not be confirmed.

Event Description

It was reported that the patient previously had a large infarct, and the vessel remained closed.In this case, the patient received treatment for occlusion of the mediastinal.Several stent retrievers and an eric device were used.The eric device was delivered through a competitor¿s microcatheter, which was removed for more aspiration volume.When the eric device was attempted to be retrieved back into the sofia catheter, the retriever broke off and remained implanted in the patient.The vessel had occluded.The treatment was aborted.The physician has no plans to treat the patient further.The patient¿s current condition is unknown.No additional information is available.

Manufacturer Narrative

Three radiographic images were provided for review.They are not labeled as to date or time.The review of the images is as follows: fluroscopic image 1: left ica dsa, subtracted, with contrast, arterial phase.There is no opacification of the entire left mca territory.The aca, pcom and pca fill normally.Fluroscopic image 2: single shot ap skull radiograph, unsubtracted, no contrast.An eric device is seen in the m2/distal m1 segments of the left mca.It is difficult to determine from the image, but there is probably a microcatheter (distal opaque marker) at the base of the eric.Fluroscopic image 3: single shot lateral skull radiograph, unsubtracted, no contrast.An eric device is seen in the m2/distal m1 segments of the left mca.It is difficult to determine from the image, but there is probably a microcatheter (distal opaque marker) at the base of the eric.These images do not explain why the eric device broke off.However, based on the review of the provided post-operative treatment note, the system disconnects from the carrier wire at high friction with the physician indicating that the eric device ruptured.Without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.The post-operative treatment note data reviewed indicates that the thrombus was present prior to deployment of the eric device, which indicates that the eric device did not contribute to the development of the reported thrombus.

Manufacturer Narrative

The following corrections were made to this medwatch report: b1 report type: adverse event was checked.H1 type of reportable event: serious injury was selected.

Event Description

See h.10.

• Brand Name: ERIC 6
• Type of Device: THROMBUS RETRIEVER CATHETER
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18166934
• MDR Text Key: 328514082
• Report Number: 2032493-2023-01061
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00810170018824
• UDI-Public: (01)00810170018824(11)230510(17)280430(10)0000360538
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2024

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
• Device Operator: Health Professional
• Device Model Number: ER176044
• Device Lot Number: 0000360538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/18/2023
• Supplement Dates Manufacturer Received: 01/08/2024; 03/12/2024
• Supplement Dates FDA Received: 01/08/2024; 03/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• 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