MAUDE Adverse Event Report: MICROVENTION, INC. LVIS 2.5X25; INTRALUMINAL SUPPORT DEVICE

Model Number 212525-CAS-D-CN

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

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 device has not been returned to the manufacturer for evaluation.

Event Description

It was reported that during treatment of a right anterior pcom aneurysm, the stent could not be resheathed.The stent was removed from the patient; however, the stent could not be withdrawn into the microcatheter completely during removal.There was no reported patient injury and the patient was reported to be "fine.".

• Brand Name: LVIS 2.5X25
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 13 enterprise; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10479988
• MDR Text Key: 205266764
• Report Number: 2032493-2020-00222
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00812636020013
• UDI-Public: (01)00812636020013(11)191024(17)220930(10)19102455A
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P170013
• 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: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 212525-CAS-D-CN
• Device Lot Number: 19102455A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2019
• 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: 71 YR
• Patient Weight: 55