MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 3.5X23MM; STENT

Model Number 172524-CASJ

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem Thrombus (2101)

Event Date 11/29/2018

Event Type  malfunction  

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, pusher, and introducer were returned for analysis.A new headway 17 was used for the investigation, as the original microcatheter used during the procedure was not returned.Upon initial investigation, there did not appear to be any damage to the stent.There did not appear to be any thrombus in the stent.The stent was reloaded into the introducer and the microcatheter without any friction.The stent deployed out of the distal end of the microcatheter as expected.The device functioned within specification.Based on the available information and investigation, the reported complaint is was unable to be confirmed.The stent was able to advanced through the microcatheter and deploy fully, and there was no evidence of thrombus.The root cause is unknown; however, the patient was not on dual antiplatelet therapy, along with possible tortuous anatomy may have caused the stent to lodge some of the thrombus onto the stent, which might have prevented the stent from opening fully.The instructions for use (ifu) identifies thrombus as potential a complication associated with use of the device.

Event Description

It was reported that the proximal portion of the lvis stent did not open fully.The stent was removed through the microcatheter, and upon inspection outside the patient, thrombus was noted in the stent.The patient was not placed on dual antiplatelet therapy.There was no reported patient injury or intervention.The patient was reported to be doing okay.

• Brand Name: LVIS JR 3.5X23MM
• Type of Device: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 8197090
• MDR Text Key: 131488944
• Report Number: 2032493-2018-00288
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00810170018589
• UDI-Public: (01)00810170018589(11)160624(17)190624(10)160624ZC1
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/24/2019
• Device Model Number: 172524-CASJ
• Device Lot Number: 160624ZC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2016
• 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: 74 YR
• Patient Weight: 73