MAUDE Adverse Event Report: MICROVENTION, INC ERIC 3; THROMBUS RETRIEVER

Model Number ER173020

Device Problem Material Separation (1562)

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

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the reported 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 not available for return to the manufacturer for analysis as it was discarded by the user.Three angiographic images and three vascular ultrasound images of the cervical carotid bifurcation area were supplied.The first angio image is a non-subtracted ap still shot at the skull base, showing the eric device deployed from the m2 to the m1 segment.Then subtracted dsas with contrast show the broken eric device with its distal wire across the origin of the ica at the bifurcation, and its proximal end at the level of the facial and lingual trunks.The ultrasound images show the broken eric device in the same position as described above.The cause of the fracture is not evident on these images.Without the return an physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.

Event Description

It was reported that an m2 occlusion was treated with an eric device.After the second retrieval the device became stuck and was withdrawn with the microcatheter and sofia catheter.The distal tip of the eric appear to be stripped from the device.The distal tip is located at the ica.The wire was unable to be retrieved.Additional thrombectomy was performed with a stent retriever successfully.The patient was reported in good condition.

• Brand Name: ERIC 3
• Type of Device: THROMBUS RETRIEVER
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15122619
• MDR Text Key: 296786720
• Report Number: 2032493-2022-00298
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00811425020807
• UDI-Public: (01)00811425020807(11)211203(17)261130(10)0000130409
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER173020
• Device Lot Number: 0000130409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• 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 Outcome(s): Other; Required Intervention