MAUDE Adverse Event Report: MICROVENTION, INC. LVIS D; INTRALUMINAL DEVICES

Model Number 213025-CAS-D-CN

Device Problem Retraction Problem (1536)

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

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged resheathing issue as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.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.

Event Description

As reported, during the procedure, the stent could not be opened into the intracranial.Then the microcatheter was locked, the stent could not be withdrawn by hard pulling from the intracranial.The procedure was then completed with a competitor stent.The patient's current condition is good.

Manufacturer Narrative

The investigation found the stent returned resheathed in the introducer with the proximal marker band detached from the pusher bodycoil.Due to the detached marker band, an undamaged in-house pusher was used for functional testing.Functional testing was performed and found the stent was able to successfully advance through an in-house microcatheter, deploy, and resheathe without resistance.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher damage, but the damage is consistent with the device experiencing forces over specification when attempting to push/pull the stent during the procedure.The microcatheter used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.The stent was returned resheathed with the pusher backed out of the introducer up to the proximal marker band; the pusher body coil was visibly detached from the marker band.The stent was retrieved from the introducer undamaged.Due to the detached pusher marker band, an undamaged in-house pusher was used for functional testing.The stent was loaded onto the in-house pusher with the returned introducer and advanced into an in-house microcatheter.The stent was advanced, deployed, and resheathed without resistance during the investigation.

Event Description

As reported, during the procedure, the stent could not be opened into the intracranial.Then the microcatheter was locked, the stent could not be withdrawn by hard pulling from the intracranial.The procedure was then completed with a competitor stent.The patient's current condition is good.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL DEVICES
• 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: 18376510
• MDR Text Key: 331376963
• Report Number: 2032493-2023-01144
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00812636020037
• UDI-Public: (01)00812636020037(11)220715(17)250630(10)0000218170
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/14/2024

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: 213025-CAS-D-CN
• Device Lot Number: 0000218170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• 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
• Treatment: HEADWAY21.
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 60 KG