MAUDE Adverse Event Report: MICROVENTION, INC. LVIS 4.5X23 (HDE); STENT

Model Number	213025-LVIS
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Codes	Ischemia (1942); Thrombus (2101)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Additional 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 device was not returned for evaluation; therefore, an analysis could not be performed.The instructions for use (ifu) identifies ischemia and neurological insufficiencies as potential complications associated with use of the device.
Event or Problem Description
It was reported that stent implantation was attempted in the carotid siphon.During deployment, the lvis stent was not opening properly around the first bend; therefore, an attempt was made to withdraw the stent back into the microcatheter for repositioning.During retraction of the delivery pusher wire, there was no effect on the stent and the pusher wire came out of the microcatheter, leaving part of the stent deployed in the vessel and part of the stent in the microcatheter.An attempt was made to remove the microcatheter and the stent together as a single unit; however, the distal end of the stent remained affixed to the vessel wall.The proximal end of the stent stretched and narrowed down as the microcatheter was removed, and was not fully apposed to the vessel wall.Approximately one hour after the procedure, a clot formed and the patient had a transient ischemic attack with signs of hemiparesis.Advanced imaging was performed, which confirmed flow abnormalities near the stent, and the patient was treated with heparin.Currently, the patient is reported to be fine.
Additional Manufacturer Narrative
The delivery wire and the microcatheter were returned for analysis.Visual examination of the delivery wire and microcatheter revealed no apparent damage or defects.The delivery wire was able to track through the microcatheter smoothly, without any friction.Based on the investigation, the complaint could not be verified, as the stent remains implanted in the patient, and appropriate testing for the reported issue could not be performed.The root cause could not be determined.

• Brand Name: LVIS 4.5X23 (HDE)
• Common Device Name: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7576479
• Report Number: 2032493-2018-00108
• Device Sequence Number: 1813346
• Product Code: NJE
• UDI-Device Identifier: 00812636022215
• UDI-Public: (01)00812636022215(11)161017(17)190930(10)16101728
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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
• Operator of Device: Other
• Device Expiration Date: 09/30/2019
• Device Model Number: 213025-LVIS
• Device Lot Number: 16101728
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention