MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X23 (HDE); STENT

Model Number	172020-LVISJ
Medical Device Problem Codes	Separation Failure (2547); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was not provided; therefore, a device history record (dhr) or lot history trending review could not be performed.The device was not returned to the manufacturer; therefore, a product analysis could not be performed.The root cause could not be determined.
Event or Problem Description
It was reported that stent-assisted coil embolization treatment of an aneurysm was attempted.After positioning the lvis jr stent at the treatment site, the stent did not deploy properly.During retraction of the delivery wire, the stent was still attached and the stent inverted on itself.After multiple attempts were made, the stent was successfully removed with a snare device.The procedure was rescheduled for treatment the following day.Final angiographic images demonstrated no evidence of thrombus in the vessel and good intracranial flow.The patient returned the next day and treatment was completed successfully without incident.
Additional Manufacturer Narrative
The stent was deployed from the left a2 to the right a1.The patient's anatomy was not unusual.During the stent deployment, the distal end of the stent expanded well, fully apposing to the vessel wall, and the stent was positioned appropriately across the neck of the aneurysm.The proximal end of the stent, however, did not fully expand and the delivery system wire would not release from the stent.During the attempt to remove the stent from the patient, the proximal end of the stent folded upward on itself, as was seen under fluoroscopy by the proximal stent markers which were visible in the mid-portion of the stent.The stent was eventually snared out from the patient.There was no adverse consequence to the patient as a result of the issue during the procedure or post-procedure.The physician confirmed the patient is currently doing well.
Additional Manufacturer Narrative
Additional information: (age or date of birth).Additional information: (sex).The patient's age and gender were provided.

• Brand Name: LVIS JR 2.5X23 (HDE)
• Common Device Name: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7584449
• Report Number: 2032493-2018-00110
• Device Sequence Number: 2063404
• Product Code: NJE
• UDI-Device Identifier: 00812636020143
• UDI-Public: (01)00812636020143(11)180221(17)210131(10)18022152Y
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 05/11/2018

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: 01/31/2021
• Device Model Number: 172020-LVISJ
• Device Catalogue Number: 172020-LVISJ
• Device Lot Number: 18022152Y
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 05/11/2018; 05/11/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 07/06/2018; 07/26/2019
• 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: 58 YR