MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X23 MM; STENT

Model Number 172020-CASJ-C

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

Patient Problem Thrombus (2101)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

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 was not available for return to the manufacturer.The root cause could not be established.The instructions for use (ifu) identifies the formation of thrombus as a potential complication associated with use of the device.

Event Description

It was reported that stent assisted coiling was performed as treatment for a saccular aneurysm in the left anterior communicating artery.The aneurysm had never ruptured and had not been previously treated.The patient had been pre-treated for one week with plavix, and platelet aggregation testing performed prior to the procedure indicated "good efficacy of plavix." the patient's pre-procedure mrs=0.The stent was implanted successfully with "perfect opening of the stent" and seven (7) embolization coils were subsequently placed in the aneurysm.During the procedure, an intra-stent thrombus developed.Tirofiban (aggrastat) was administered directly at the stent entrance, followed by an intravenous bolus injection, which completely resolved the thrombus.Final control angiogram demonstrated no intracranial bleeding.The aneurysm was completely obliterated and the patient remains asymptomatic.The patient's mrs=0 at the time of hospital discharge.

• Brand Name: LVIS JR 2.5X23 MM
• Type of Device: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 9288535
• MDR Text Key: 165380234
• Report Number: 2032493-2019-00258
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00810170019111
• UDI-Public: (01)00810170019111(11)181106(17)211031(10)18110653G
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Model Number: 172020-CASJ-C
• Device Lot Number: 18110653G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR