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

Model Number	213041-LVIS-D-PMA
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11182426
• Report Number: 2032493-2021-00017
• Device Sequence Number: 16861553
• Product Code: QCA
• UDI-Device Identifier: 00842429100967
• UDI-Public: (01)00842429100967(11)180619(17)210531(10)18061953B
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P170013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1