MAUDE Adverse Event Report: MICROVENTION, INC. LVIS D; INTRACRANIAL COIL-ASSISR STENT

Model Number 212517-CAS-D-CN

Device Problem Component Missing (2306)

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

Event Date 07/13/2022

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 delivery wire was stated to be available for evaluation but has not yet been returned.If the device is received the investigation will be performed and a supplemental report will be submitted.

Event Description

It was reported that an lvis d implant stent was identified to be missing when the delivery wire was removed from its packaging.There was no patient involvement.

Manufacturer Narrative

Summary device evaluation: the investigation of the returned device found only the pusher, dispenser hoop, and product pouch present upon receipt.The stent and introducer were not returned.As a component other than the stent was 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 as described in the reported event.Furthermore, the build records indicate that the devices in this lot (210607524) passed all inspections; therefore, this device was verified to have the stent present within package at the time the device was shipped.

• Brand Name: LVIS D
• Type of Device: INTRACRANIAL COIL-ASSISR STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15577448
• MDR Text Key: 307017761
• Report Number: 2032493-2022-00402
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00812636020075
• UDI-Public: (01)00812636020075(11)210607(17)240531(10)210607524
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212517-CAS-D-CN
• Device Lot Number: 210607524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2021
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 63 KG