MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X17MM; STENT

Model Number 172014-CASJ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombus (2101)

Event Date 12/11/2018

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.The stent was implanted in the patient and the remainder of the device was not returned to the manufacturer; therefore, a product analysis could not be performed.The root cause is unknown.The instructions for use (ifu) identifies thrombus as a potential complication associated with use of the device.

Event Description

It was reported that embolization of an unruptured aneurysm in the right middle cerebral artery was performed on (b)(6) 2018 on a patient enrolled in the lepi clinical trial.The lvis jr.Was placed in the m1/m2 straight artery (upper branch), followed by the implantation of 2 coils.During the procedure, an intra-stent thrombus was identified, which was successfully treated with aggrastat.The event was reported to be mild in severity and resolved without sequelae that day.The patient was discharged eight (8) days post procedure, with a mrs score of 0.The patient will be monitored per clincal trial protocol.

Manufacturer Narrative

Additional information: the principal investigator (physician) indicated the event was not associated with a malfunction of the lvis jr.Pma/510k: correction.

• Brand Name: LVIS JR 2.5X17MM
• Type of Device: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8602121
• MDR Text Key: 144797715
• Report Number: 2032493-2019-00139
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00810170019104
• UDI-Public: (01)00810170019104(11)180502(17)210430(10)18050253B
• Combination Product (y/n): N
• PMA/PMN Number: K130005
• 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: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 172014-CASJ
• Device Lot Number: 18050253B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR