MAUDE Adverse Event Report: MICROVENTION, INC. LVIS 5.5X30; STENT

Model Number 214035-LVIS-D

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided; therefore, a review of the approved device history records or lot history trending review could not be performed.The device remains implanted in the patient and the remainder of the device was discarded at the user facility; therefore, a device analysis was unable to be performed.The root cause is unknown.

Event Description

It was reported that the lvis stent was deployed for the treatment of a right cavernous internal carotid artery aneurysm.Post-deployment imaging demonstrated incomplete stent opening in the mid-section of the stent.Attempts made to re-cross and open were unsuccessful, resulting in the proximal portion of the stent herniating into the aneurysm sac.The treatment was aborted as the patient became "difficult and uncooperative".The patient was administered a dual antiplatelet therapy as post-procedure routine and not in response to the event.There was no reported patient injury.

• Brand Name: LVIS 5.5X30
• Type of Device: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 8238399
• MDR Text Key: 132793764
• Report Number: 2032493-2019-00007
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130005
• 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: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 214035-LVIS-D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2018
• 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 Age: 85 YR
• Patient Weight: 64