MAUDE Adverse Event Report: MICROVENTION INC. ERIC 4; THROMBUS RETRIEVER CATHETER

Model Number ER174030

Device Problem Break (1069)

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

Event Date 10/14/2023

Event Type  Injury  

Event Description

It was reported that during a thrombectomy procedure, failed attempts were made to capture the calcified colt using several retrievers.The eric device was then used as the last attempt to retrieve the calcified clot.Upon retrieval of the eric device from the m1 segment down to the tip, it broke between the 2nd and 3rd cage resulting in its distal part remaining above the occlusion.As a result, vascular injury occurred as there was contrast medium leakage in the subarachnoid space.The vascular damage above the occlusion which consisted of the calcified piece had occluded the damaged area and remains implanted.The other broken portion was removed from the patient and is being returned.Patient came in with a large infarction and this condition is the same since the m1 occlusion after a tavi procedure.No further treatment is planned to remove the remaining implanted part of the broken eric.

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 returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Manufacturer Narrative

The pusher was returned with two spheres still attached, which is consistent with the reported complaint as well as the images and video provided by the physician.Since the entire device was not returned, it is not possible to investigate the cause of breakage but that it is consistent with device experiencing forces above specifications.Radiographic images and powerpoint were reviewed: two radiographic images, a powerpoint file (containing a non-contrast bone window ct scan of the high neck and head) and a 3.92 gb folder with two videos are supplied.None are labeled as to date or time.Image 3: ap single-shot radiograph, unsubtracted, no contrast centered on right skull base.The distal part of the broken eric (distal radiopaque marker and 2 cages) is seen in the area of the m1 segment of the right mca.A calcific density is seen between the two cages, likely representing the calcified clot mentioned in the event description.Image 4: same as image 3, but in lateral projection.Powerpoint file: non-contrast bone window ct scan of the high neck and head.The broken distal eric is seen in the right mca m1 segment, with the calcified clot in between the two cages.There are mild to moderate atherosclerotic calcifications of both carotid siphons.The brain parenchyma cannot be well evaluated as these are bone windows.There is no gross hemorrhage, and there is no midline shift.Videos: right ica ap subtracted roadmap, with contrast: a guiding catheter is in the cervical ica.In the early part, an intact eric device (with its delivery microcatheter) is seen in the right mca m1 segment and the supraclinoid ica.Then, traction is applied to the eric; it initially comes back some, but eventually fractures with the distal two cages ending up in the right mca m1 segment.The proximal cages are successfully retrieved inside the guiding catheter, along with the delivery microcatheter.Right ica lateral subtracted roadmap, with contrast: same as the previous video, but in lateral projection.These images and videos do not explain why the eric device fractured.

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.

• Brand Name: ERIC 4
• 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: 18050618
• MDR Text Key: 327174546
• Report Number: 2032493-2023-01023
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00810170018800
• UDI-Public: (01)00810170018800(11)190214(17)240131(10)19021411R
• 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: 03/13/2024

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 Expiration Date: 01/31/2024
• Device Model Number: ER174030
• Device Lot Number: 19021411R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 12/20/2023; 03/12/2024
• Supplement Dates FDA Received: 01/05/2024; 03/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2019
• 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