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

Model Number 172516-LVISJ-C-PMA

Device Problem Activation Failure (3270)

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

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination did not reveal any production-relatedissues relevant to the complaint that occurred during manufacturing of the device.The reported complaint is unconfirmed as the stent was able to fully open upon deployment during the investigation.The distortion of the proximal long loops is consistent with the stent being retrieved from the vessel with a snare during the procedure.The distal long loops were damaged while loading the stent during the investigation.

Event Description

It was reported that after deploying the lvis jr.Stent, the back half of the stent leading to the proximal end did not open and appeared flattened out.The stent was removed with a snare.There was no reported patient injury.

• Brand Name: LVIS JR.
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12662138
• MDR Text Key: 277613742
• Report Number: 2032493-2021-00415
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429100837
• UDI-Public: (01)00842429100837(11)201021(17)230930(10)20102155F
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2021

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: 09/30/2023
• Device Model Number: 172516-LVISJ-C-PMA
• Device Catalogue Number: 172516-LVISJ
• Device Lot Number: 20102155F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2020
• 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: 67 YR