MAUDE Adverse Event Report: MICROVENTION, INC LVIS JR 3.5X28; INTRACRANIAL COIL-ASSIST STENT

Model Number MV-L352817

Device Problem Activation Problem (4042)

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

Event Date 07/07/2022

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances 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 remains implanted in the patient and is therefore not available for return to the manufacturer for analysis.On this basis, at this time, the event as described could not be confirmed.

Event Description

As reported, during a coil embolization using the lvis stent for an aneurysm at the bifurcation of the basilar artery and the left superior cerebellar artery, the stent did not open normally.The flare marker at the distal end did not appear to be fully opened; it was not apposite to the vessel.The other portion was completely expanded.The physician decided to detach the stent.It was noted that the patient's anatomy was torturous.The patient did not exhibit any symptoms and two days post op the patient's condition remained the same.

Manufacturer Narrative

A single dsa image was provided.It is an ap transfacial view of a right vertebral angiogram.It shows an approximately 6 mm round aneurysm of the left sca (no measurements provided).The angle between the sca and the basilar is quite acute, over 90 degrees, likely around 130 degrees, based on this single projection.No images of the incompletely opened distal markers of the lvis are supplied.It is possible that the acute angle between the sca and basilar arteries contributed to the poor opening of the distal lvis.Without the return and physical evaluation of the device, the investigation cannot determine if a condition existed that would have caused or contributed to the reported event.

• Brand Name: LVIS JR 3.5X28
• Type of Device: INTRACRANIAL COIL-ASSIST STENT
• 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: 15113334
• MDR Text Key: 296690954
• Report Number: 2032493-2022-00292
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987350616630
• UDI-Public: (01)04987350616630(11)190910(17)220831(10)19091053Z
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/12/2022

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 Expiration Date: 08/31/2022
• Device Model Number: MV-L352817
• Device Lot Number: 19091053Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1