MAUDE Adverse Event Report: MICROVENTION, INC LVIS 4.5X23 MM; INTRALUMINAL SUPPORT DEVICE

Model Number 213025-CAS-D

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

Patient Problems Headache (1880); Ischemia (1942); Vertigo (2134)

Event Date 07/11/2019

Event Type  Injury  

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 was not returned for evaluation; therefore, an analysis could not be conducted.The root cause cannot be determined.The instructions for use (ifu) identifies transient ischemic attack as a potential complication associated with use of the device.

Event Description

It was reported that on (b)(6) 2019, stent-assisted coil embolization was performed for a saccular aneurysm in the left vertebral artery on a patient enrolled in the (b)(6) clinical trial.At the end of the procedure, the degree of aneurysm occlusion using the raymond-roy scale was classified as "complete obliteration." the patient was discharged with an mrs=0.Sometime after discharge, the patient presented with headaches and vertigo, and on (b)(6) 2019, an mri was performed, which demonstrated an ischemic stroke in the basilar vertebral territory.The patient was hospitalized from (b)(6) 2019 to (b)(6) 2019.The patient's nihss score=0.The patient's prescribed daily dose of kardegic was increased from 75mg to 160mg.The event was determined by the study physician to be transient, without seriousness, and with mild severity.The event was reported to be resolved without sequelae 12 days after the procedure on (b)(6) 2019.The patient will be monitored closely per clinical trial protocol.

Manufacturer Narrative

Additional information provided in a report of hospitalization that was received from the clinical site.On (b)(6) 2019, angiography was performed, which demonstrated a stenosis at the entrance of the stent, but no intra-stent clot, and without indication for a complementary endovascular procedure.At the time of hospital discharge on (b)(6)2019, the patient no longer had headaches or dizziness.The patient walks without assistance and can climb stairs without difficulty.

• Brand Name: LVIS 4.5X23 MM
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9013981
• MDR Text Key: 160441475
• Report Number: 2032493-2019-00216
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00812636020808
• UDI-Public: (01)00812636020808(11)180426(17)210331(10)18042655X
• Combination Product (y/n): N
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

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: Other
• Device Expiration Date: 03/31/2021
• Device Model Number: 213025-CAS-D
• Device Lot Number: 18042655X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 48 YR