MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 3.5X18 MM; STENT

Model Number 172516-CASJ

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2019

Event Type  Injury  

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.

Event Description

It was reported that stent-assisted coil embolization was performed as treatment for an unruptured saccular aneurysm in the left internal carotid artery.During deployment of the lvis jr.Stent, the delivery wire was advanced in the parent vessel; however, the delivery wire collided with a bifurcation, which resulted in the detachment of the delivery wire tip.The lvis jr.Was fully deployed and coils were placed in the aneurysm using the jailed catheter technique.After coil treatment, an atlas stent was implanted to affix the detached delivery wire tip to the carotid wall.Post-procedure angiography confirmed that the aneurysm was completely obliterated.There was no reported adverse patient sequelae as a result of the issue.The patient was discharged from the hospital 5 days later with an mrs score of 1.

Manufacturer Narrative

Corrected data: the actual complaint identifier number is (b)(6).Corrected data: the device was received for evaluation.Only the pusher was returned for evaluation; the stent was not returned, as it was implanted in the patient.A review of customer supplied images showed that the tip of the pusher separated from the device.The images do not provide evidence that identifies the cause for the break.The distal tip of the pusher was found to be broken off and not returned.The bend at the break appears to be near 90 degrees off-axis.No other damages were noted on the pusher.The device was sent to a third party for a detailed analysis of the break location.The conclusion of the report provided indicates the broken end was severely bent backwards upon itself, which is consistent with it being kinked.The fracture displayed very fine ductile dimples, which indicates a ductile overload fracture.The reported complaint is confirmed.The physical analysis of the returned device found the tip of the pusher to be kinked and broken off.A detailed analysis of the kink/break location determined the break to be consistent with the wire being bent into a kink and then separating due to a shear/tensile overload.No evidence of corrosion or other anomalous conditions that could facilitate premature fracture was found, and there was no indication from the returned pusher that a manufacturing defect was present.

• Brand Name: LVIS JR 3.5X18 MM
• Type of Device: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8787345
• MDR Text Key: 150961737
• Report Number: 2032493-2019-00170
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00810170018572
• UDI-Public: (01)00810170018572(11)170912(17)200831(10)17091255E
• 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: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Model Number: 172516-CASJ
• Device Lot Number: 17091255E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR