MAUDE Adverse Event Report: MICROVENTION, INC. LVIS 2.5X17; STENT

Model Number 212517-CAS

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

Patient Problem Numbness (2415)

Event Date 03/29/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was provided.A search for non-conformance 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 stent remains implanted in the patient; therefore, a product analysis could not be performed.The root cause is unknown.

Event Description

It was reported that during the treatment of a left side anterior internal carotid artery aneurysm, the lvis stent was deployed; however, carried two (2) coils to the far end of the blood vessel.The stent remains implanted in the patient.A new lvis stent was deployed successfully.The patient was reported to have numbness of hands and feet post procedure, and gradually recovered after a week of drug treatment.The patient is reported to be doing fine.

• Brand Name: LVIS 2.5X17
• 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: 8593170
• MDR Text Key: 144525393
• Report Number: 2032493-2019-00135
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00812636020075
• UDI-Public: (01)00812636020075(11)180731(17)210630(10)18073152J
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 212517-CAS
• Device Lot Number: 18073152J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2018
• 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: 52 YR
• Patient Weight: 60