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

Model Number MV-L401721

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

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

Event Date 05/22/2023

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged product issue / event 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.Device has not yet been returned.

Event Description

It was reported, unable to advance the stent due to resistance.Resistance was felt when the stent was inserted into a microcatheter.The stent was therefore withdrawn and removed from the patient.The delivery wire tip was found to be broken after removal from the patient.The stent was not used and was replaced with another stent to continue the procedure.Subsequently, the procedure was successfully completed with no health damage to the patient.

Manufacturer Narrative

The stent was returned loaded in the introducer.The distal tip of the pusher was found to be damaged.The stent was advanced into a new microcatheter for investigation and did not encounter resistance.The stent was able to deploy normally during the investigation.The proximal marker band od is specified at 0.0175¿ (+/-0.0003), and the returned pusher measured 0.0174¿.The introducer distal tip id is specified at 0.0215¿ (+0.0001/-0.0005), and the returned introducer measured 0.0214¿.The investigation of the returned stent system found the pusher distal tip damaged; however, no break condition was observed on the pusher distal tip as described in the reported event.Furthermore, the device was able to enter an in-house microcatheter, advance, and deploy without any resistance during functional testing.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.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT 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: 17075093
• MDR Text Key: 317002959
• Report Number: 2032493-2023-00780
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987892063138
• UDI-Public: (01)04987892063138(11)200819(17)230731(10)20081956N
• 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: 05/22/2023

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 Expiration Date: 07/31/2023
• Device Model Number: MV-L401721
• Device Lot Number: 20081956N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 06/16/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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