MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 3.5X23; STENT

Model Number	172524-LVISJ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2019
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 pusher and carotid stent delivery system was returned for analysis.Upon initial investigation, the distal tip of the pusher appeared to have been damaged, and the platinum marker detached stainless steel coils are not present at the distal tip of the pusher.The distal marker band to the distal tip of the pusher was measured to see how much was detached; approximately 17mm remained, thus meaning that approximately 20mm of the pusher was detached.Based on the available information and investigation, the reported complaint is confirmed; the failure mode of the pusher was consistent with a kink overload resulting in the fracture.The broken end was severely bent backwards upon itself and twisted, which is consistent with it being kinked.The root cause of this complaint is due to the wire being twisted into a kink and then pulled away causing a shear/tensile overload.
Event or Problem Description
It was reported that during treatment of a left-side, posterior communicating aneurysm, the tip of the delivery wire of the lvis jr stent detached in the internal carotid artery at the neck of the blister aneurysm.This was noticed after the remainder of the lvis stent was re-sheathed and removed from the body.Another lvis jr.Stent was then placed to secure the detached segment of the stent to the wall of the vessel.There was no reported injury and the patient was noted to be in fair condition post-procedure.

• Brand Name: LVIS JR 3.5X23
• Common Device Name: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8346185
• Report Number: 2032493-2019-00028
• Device Sequence Number: 19290981
• Product Code: NJE
• UDI-Device Identifier: 00842429100844
• UDI-Public: (01)00842429100844(11)180509(17)210430(10)18050953EM
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2019

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: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 172524-LVISJ
• Device Catalogue Number: 172524-LVISJ
• Device Lot Number: 18050953EM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/15/2019
• 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
• Patient Age: 52 YR