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

Model Number 214022-CAS-D-CN

Device Problems Break (1069); Difficult or Delayed Positioning (1157)

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

Event Date 06/19/2023

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 delivery system of the device and two fluoroscopy images were returned to the manufacturer for analysis and the investigation is currently underway.A supplemental report will be submitted when the investigation is completed.

Event Description

It was reported that the lvis stent was prepped and hydrate normally for use in an unspecified procedure.After the stent was released, the tail end of the stent did not open properly but after repeat adjustment, the stent opened well.Reportedly, when the stent delivery guide wire was retracted, it was found that the head end of guide wire was broken and floated in the blood vessel.The physician successfully placed a stent to affix the broken part of guide wire against the vessel wall.The patient is fine.

Manufacturer Narrative

Additional information received indicating the lvis stent assisted coil embolization was used to treat a patient with a recurrent aneurysm.After the lvis stent was partially released, the physician started filling the coils (non-microvention).After filling completion, the lvis stent was not released properly during the release process.The physician had to adjust and pulled the stent several times and the stent released fine.However, when retracted, the guidewire was found broken in the vessel.The physician used a non-microvention stent to affix the broken piece of guide wire against the vessel wall.The investigation is still on going.A supplemental report will be submitted at the conclusion of investigation.

Manufacturer Narrative

Additional information: h6, h10 (summary of device evaluation).Summary of device evaluation: investigation conclusion: only the pusher was returned for evaluation.The investigation of the returned pusher found the distal end to be kinked and fractured.The condition of the returned pusher appears to align with the description of the reported event.However, the review of the provided medical imaging could not verify if the pusher fragment separated and remained within the patient as described in the reported event.Therefore, the full reported event could not be verified based on the known information.The pusher was sent to a third-party evaluator for further analysis of the observed break condition.Per the third-party investigation, significant pitting/corrosion was observed on the fractured surface of the pusher component.However, the analysis suggests the unit broke due to a mechanical failure and that the corrosion damage occurred after removal from the patient.It is unknown when the corrosive species were introduced to the pusher, but it is likely a result of disinfection, cleaning, and/or storage of the device after removal from the patient.

• Brand Name: LVIS D
• 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: 17375421
• MDR Text Key: 319549162
• Report Number: 2032493-2023-00858
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429115930
• UDI-Public: (01)00842429115930(11)220913(17)250831(10)0000256916
• 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,Followup
• Report Date: 07/06/2023

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: 214022-CAS-D-CN
• Device Lot Number: 0000256916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/22/2023
• Supplement Dates Manufacturer Received: 08/18/2023; 09/28/2023
• Supplement Dates FDA Received: 09/14/2023; 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• 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): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 61 KG