MAUDE Adverse Event Report: MICROVENTION, INC. LVIS EVO; INTRACRANIAL COIL-ASSIST STENT

Model Number LEV2517-MVE

Device Problem Retraction Problem (1536)

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

Event Date 06/16/2023

Event Type  malfunction  

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 reported available for return for analysis, but has not yet been received; therefore, the alleged product issue cannot be confirmed at this time.If the device or additional information is received, a supplemental report will be submitted.

Event Description

It was reported that the physician was treating an aneurysm on the left internal carotid artery (ica).After treating the aneurysm with coils, the implantation of a lvis evo stent was planned.The stent was placed through a microcatheter when it needed to be repositioned, it was not possible to retract the stent into the microcatheter.The physician was able to remove the lvis stent and microcatheter together out of the patient and used a new set of lvis evo and microcatheter of the same size, and successfully completed the procedure with good results.No injury was caused and the patient is "doing well.".

Manufacturer Narrative

Additional information: d10 (date device received), d11, h6, h10 (summary device evaluation).Summary of device evaluation: the microcatheter was the only item returned for evaluation.The investigation found the returned microcatheter flattened at 9cm from the distal tip.The flattened section of the microcatheter may have caused or contributed to the reported retraction issue; however, as the lvis evo stent system used during the procedure was not returned for evaluation, this investigation could not test or assess the interaction between the two devices and therefore, this complaint is considered non-verifiable.The physical evaluation of the microcatheter could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the microcatheter experiencing forces over specification.

• Brand Name: LVIS EVO
• Type of Device: INTRACRANIAL COIL-ASSIST STENT
• 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: 17308217
• MDR Text Key: 319786188
• Report Number: 2032493-2023-00841
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103432
• UDI-Public: (01)00842429103432(11)230310(17)260228(10)0000332174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170013
• 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
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LEV2517-MVE
• Device Lot Number: 0000332174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• 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
• Treatment: HEADWAY 17
• Patient Age: 60 YR
• Patient Sex: Male