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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Death  

Manufacturer Narrative

The lot number was not provided; therefore, a review of the device history record (dhr) could not be performed.The device was implanted in the patient and unavailable for return to the manufacturer for analysis; therefore, product involvement in the complication, if any, cannot be confirmed.Article bibliography: kim, min jeoung, et al."endovascular treatment for large (> 10 mm) basilar tip aneurysms: a retrospective case series." acta neurochirurgica (2022): 1-7.

Event Description

As reported through the march 9, 2022 online journal article titled, "endovascular treatment for large (> 10 mm) basilar tip aneurysms: a retrospective case series," one patient (patient # 7) that had presented with a ruptured basilar tip aneurysm (bta) and received endovascular treatment (y-sac) with two lvis jr.Stents, between january 2009 and december 2019, expired at an unknown date.The patient was reported to have an initial hunt-hess grade (hhg) of "4".The aneurysm measured 10.5mm width x 8.8mm length x 10.6mm neck.The cause of death is unknown.

• Brand Name: LVIS JR.
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14030321
• MDR Text Key: 288766660
• Report Number: 2032493-2022-00133
• Device Sequence Number: 1
• Product Code: QCA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death