MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X23MM; STENT

Model Number 172020-CASJ

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The stent was discarded with the microcatheter at the user facility; therefore, a product analysis could not be performed.The root cause is unknown.

Event Description

It was reported that during the treatment of an unruptured aneurysm in the left anterior communicating artery, the embolization coil was pulled into the parent artery.Two lvis stents were used to affix the coil to the vessel wall; however, when the microcatheter was removed, the stent was pulled out of position to the distal internal carotid artery.A snare device and intermediate catheter were used to successfully bring the lvis stent to the femoral sheath.There was no reported patient injury.The patient was reported to be doing good.

Manufacturer Narrative

Two images were provided by the distributor for review.The image analysis is limited by the following: there was no text or chronology information provided with the two images.No real time fluoroscopic imaging was provided, and there is no contrast seen on the images provided.The first image shows what appears to be two lvis jr.Stents.The second image appears to show only one lvis jr.Stent.Due to limited information provided and the lack of a returned device, the complaint is non-verifiable.Based on the provided images, there is evidence that an lvis jr.Appears to have been removed after placement in the patient using a stent retriever; however, the images provided by the user do not provide conclusive evidence of the lvis jr.Unintentionally detaching in the parent artery as described in the complaint.Additionally, the lack of contrast, accompanying text, chronology information, and real time fluoroscopic imaging, prevent drawing any definitive conclusions based on the images provided.

• Brand Name: LVIS JR 2.5X23MM
• Type of Device: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8547614
• MDR Text Key: 143022952
• Report Number: 2032493-2019-00104
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00810170019111
• UDI-Public: (01)00810170019111(11)170306(17)200229(10)170306RC4
• Combination Product (y/n): N
• PMA/PMN Number: K130005
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 172020-CASJ
• Device Lot Number: 170306RC4
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 55