MAUDE Adverse Event Report: MICROVENTION, INC. LVIS EVO 4.0X31MM; INTRALUMINAL SUPPORT DEVICE

Model Number LEV4031-MVE

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2023

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 investigation of the returned device found only the pusher and introducer present upon receipt.The stent, dispenser hoop, microcatheter, and product pouch were not returned.The pusher was found kinked at 144cm, 91cm, 77cm, 38cm, and 24cm from the proximal end.The physical evaluation of the pusher could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.As components other than the stent were not returned and no documentation of the package as it was opened during the procedure was provided, this evaluation could not verify the absence of the stent within the package.The build records indicate that the devices in this lot (0000208591) passed all loading and pre-packaging inspections; therefore, this device was verified to have the stent present within package at the time the device was shipped.

Event Description

It was reported that there was no stent observed inside the introducer sheath.The case was completed with another stent with no reported issues.There was no patient injury reported.

• Brand Name: LVIS EVO 4.0X31MM
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16392043
• MDR Text Key: 309919935
• Report Number: 2032493-2023-00574
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103586
• UDI-Public: (01)00842429103586(11)220620(17)250531(10)0000208591
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2023

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 Model Number: LEV4031-MVE
• Device Lot Number: 0000208591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2022
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 80 KG