MAUDE Adverse Event Report: MICROVENTION, INC. LVIS 3.5X22X18; STENT

Model Number MV-L352221

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.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 has been returned for evaluation.The investigation is currently ongoing.

Event Description

It was reported that during stent-assisted coiling of an aneurysm, the tip of the stent delivery wire detached in the microcatheter.Following an unsuccessful attempt to aspirate the tip from the microcatheter with a syringe, the tip was intentionally pushed out of the microcatheter into the aneurysm by the embolization coil that was advanced into the aneurysm as part of the planned procedure.Additional coils were placed and the procedure was successfully completed.There was no reported patient injury.

Manufacturer Narrative

The pusher was returned for evaluation.Upon initial inspection, the pusher appeared to be damaged.The device was sent for sem analysis.The sem report stated the pusher "displayed a 'cup cone' fracture with ductile dimples (the results of microvoid coalescence that occurs during tensile overload of ductile materials).The fracture mode is simple tensile overload with no mechanical defects facilitating the failure.The reported complaint is confirmed.The investigation of the returned lvis system found the pusher to be damaged.The damaged segment was sent out for sem analysis; the analysis of the break revealed it was caused by tensile forces.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.No other notable conditions were found during the investigation.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report or the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.

• Brand Name: LVIS 3.5X22X18
• Type of Device: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9493052
• MDR Text Key: 188869943
• Report Number: 2032493-2019-00293
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987892041457
• UDI-Public: (01)04987892041457(11)190311(17)220228(10)19031153X
• Combination Product (y/n): N
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: MV-L352221
• Device Lot Number: 19031153X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1