MAUDE Adverse Event Report: MICROVENTION, INC. LVIS 3.5X22 MM; INTRALUMINAL SUPPORT DEVICE

Model Number 212525-CAS-D

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2020

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 device was returned to the manufacturer for evaluation along with the microcatheter.The stent was returned slightly deployed from the tip of the microcatheter.As the stent was returned in this condition and the complaint stated that the stent was unable to be fully recaptured, it was tested if the stent could be retracted into the catheter.In the state that it was returned, the stent was able to be recaptured into the microcatheter without any friction.The reported complaint is unconfirmed as the stent was able to be recaptured during testing.No damage or other anomaly that would have caused or contributed to the reported complaint was discovered.The root cause of this complaint may have been due to tortuous anatomy at the vertebral artery preventing the stent from being recaptured into the microcatheter.

Event Description

It was reported that stent deployment was attempted in the vertebral artery.During the procedure, the stent was not able to be retracted completely into the microcatheter.The stent was removed together with the microcatheter with approximately 0.7cm of the stent protruding from the distal tip of the microcatheter.There was no reported patient injury or additional intervention.The patient's current condition is reported to be "normal.".

• Brand Name: LVIS 3.5X22 MM
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 13 enterprise; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10455040
• MDR Text Key: 204416368
• Report Number: 2032493-2020-00228
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00812636020785
• UDI-Public: (01)00812636020785(11)200507(17)230430(10)20050754N
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 07/27/2020

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: 04/30/2023
• Device Model Number: 212525-CAS-D
• Device Lot Number: 20050754N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2020
• 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
• Patient Age: 50 YR
• Patient Weight: 69