MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 3.5X23 MM; INTRALUMINAL SUPPORT DEVICE

Model Number 172524-CASJ-C

Device Problems Retraction Problem (1536); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

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 device was returned to the manufacturer for analysis.The investigation is underway.

Event Description

It was reported that stent-assisted coil embolization was performed as treatment for an a1 internal carotid artery (ica) bifurcation aneurysm.During stent deployment, almost the entire stent had been released, but the proximal flared ends became stuck inside the microcatheter.Efforts were made to completely release the stent or to resheath it, but they were unsuccessful.They entire stent system was removed together from the patient.There was no reported patient injury or additional intervention.The patient has been discharged from the hospital.

Manufacturer Narrative

The stent, pusher, and microcatheter were returned for evaluation.Upon initial inspection, the stent was positioned outside of its delivery system and was too damaged for further analysis.The cause of the event cannot be confirmed, but it is alleged to be related to tortuous anatomy.No notable conditions were identified on the other returned components that would have caused or contributed to the reported complaint.

• Brand Name: LVIS JR 3.5X23 MM
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10411589
• MDR Text Key: 203341436
• Report Number: 2032493-2020-00204
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00810170018589
• UDI-Public: (01)00810170018589(11)190627(17)220531(10)19062755A
• Combination Product (y/n): N
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

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: Other
• Device Expiration Date: 05/31/2022
• Device Model Number: 172524-CASJ-C
• Device Lot Number: 19062755A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR