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

Model Number UNKNOWN

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

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 02/20/2023

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the devices' part/lot number combination could not be performed as the lot and part numbers are unknown.The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging were requested and not provided.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The event as described could not be confirmed.If procedural or medical imaging is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.

Event Description

It was reported that lvis d stent was implanted in a patient to treat ophthalmic aneurysm.Reportedly at 5-year follow up a mra was performed, and it was found that the device was occluded.The occlusion occurred between 2-5 years post implantation.Reportedly during index procedure, the stent did not open well, and the physician utilized balloon angioplasty to fully open the device.No further intervention was performed.The patient condition and outcome were reported to be good.

Manufacturer Narrative

Additional information/b5: the model and lot number for the lvis blue/d is unavailable.The case was 5 years ago and the physician did not want to go back and provide report and they did not provide any images.Summary: items returned: n/a.Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Batch review: a search for non-conformances associated with this part/lot number combination could not be performed as this information was not available at the time this investigation was performed.Complaint system review: a search of the complaint handling system could not be performed to determine if other similar complaints exist for this batch number, because the batch number was not provided for the product on this complaint file.Ifu review (additional information can be found in the ifu): potential complications: possible complications include but are not limited to the following: hematoma at the puncture site; perforation or dissection of the vessel(s); intravascular spasm; hemorrhaging; rupture or perforation of aneurysm; coil herniation; device migration; neurologic insufficiencies including stroke and death; ischemia; vascular occlusion; vessel stenosis; incomplete aneurysm occlusion; pseudoaneurysm formation; distal embolization; headache; infection; reaction to contrast agents including severe allergic reactions and renal failure.Investigation conclusion: the physical device was not available for evaluation to determine if a condition existed that would have caused or contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.

Event Description

See h10.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL DEVICES
• 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: 16761121
• MDR Text Key: 313498563
• Report Number: 2032493-2023-00672
• Device Sequence Number: 1
• Product Code: QCA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

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
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/19/2023
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female