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

Model Number MV-L452321

Device Problems Device-Device Incompatibility (2919); Activation Failure (3270)

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

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance 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 reported complaint is unconfirmed as the stent was able to advance into and track through the microcatheter without resistance during the investigation.The investigation found no other damage or anomaly that would have contributed to the reported complaint.

Event Description

It was reported that after preparation of an lvis d stent, the stent was inserted into microcatheter and resistance was felt.The microcatheter was advanced to the treatment site, an aneurysm, and the stent was attempted to be deployed.When the stent came out of the microcatheter about 5cm, high resistance was felt.The stent was then attempted to be withdrawn, but could not be withdrawn due to the resistance.The stent was withdrawn along with the microcatheter as it was and successfully removed from the patient.The procedure was completed successfully with another device.There was no reported patient injury or intervention.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terry callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 11579854
• MDR Text Key: 243182267
• Report Number: 2032493-2021-00097
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987350609373
• UDI-Public: (01)04987350609373(11)200616(17)230531(10)20061657F
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: MV-L452321
• Device Lot Number: 20061657F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2020
• 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