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

Model Number 172014-CASJ-C

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

Event Type  malfunction  

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 has not been returned to the manufacturer for evaluation.

Event Description

It was reported that during treatment of an acom artery aneurysm, an lvis jr.Stent was difficult to deploy.During the attempt to resheath the stent for repositioning, the stent could not be completely resheathed.The partially resheathed stent and microcatheter were withdrawn together from the patient.There was no reported intervention or patient injury.

• Brand Name: LVIS JR 2.5X17 MM
• Type of Device: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 9359950
• MDR Text Key: 188873167
• Report Number: 2032493-2019-00275
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00810170019104
• UDI-Public: (01)00810170019104(11)180807(17)210731(10)18080752N
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2019

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: Other
• Device Expiration Date: 07/31/2021
• Device Model Number: 172014-CASJ-C
• Device Lot Number: 18080752N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2018
• 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 Age: 53 YR
• Patient Weight: 62