MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X13 MM; INTRALUMINAL SUPPORT DEVICE

Model Number 172010-CASJ-C

Device Problem Migration (4003)

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

Event Date 09/23/2020

Event Type  Injury  

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 reported complaint could not be verified, as the stent was too damaged to be evaluated for the investigation.The damage is consistent with the device experiencing excessive forces likely caused by the use of the snare device, as described in the details provided.The build record indicated that the device met dimensional and visual inspection prior to packaging.

Event Description

It was reported that treatment was performed for a left middle cerebral artery (mca) aneurysm.After the stent was deployed, the stent migrated proximally.The stent was removed with a snare device.There was no reported patient injury.The patient's current condition is reported to be "good.".

• Brand Name: LVIS JR 2.5X13 MM
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 10731610
• MDR Text Key: 212978232
• Report Number: 2032493-2020-00308
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00810170019098
• UDI-Public: (01)00810170019098(11)200123(17)221231(10)20012353L
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 172010-CASJ-C
• Device Lot Number: 20012353L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 58