MAUDE Adverse Event Report: MICROVENTION, INC. LVIS D; INTRALUMINAL SUPPORT DEVICE

Model Number 213041-LVIS-D-PMA

Device Problem Activation Failure (3270)

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

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance 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 the delivery system was not returned to the manufacturer for analysis.Intraprocedural or post-procedural images were not provided for review; therefore, the alleged product issue cannot be confirmed.

Event Description

It was reported that after deployment of an lvis in the internal carotid artery (ica) to treat a ruptured aneurysm, the proximal markers of the stent did not open.The markers could not be opened with the catheters.No additional intervention was performed.Final angiography demonstrated a mostly patent ica and the aneurysm was successfully coiled.There was no reported patient injury or sequela.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 11182426
• MDR Text Key: 227753528
• Report Number: 2032493-2021-00017
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429100967
• UDI-Public: (01)00842429100967(11)180619(17)210531(10)18061953B
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Model Number: 213041-LVIS-D-PMA
• Device Catalogue Number: 213041-LVIS
• Device Lot Number: 18061953B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2018
• 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