MAUDE Adverse Event Report: MICROVENTION, INC. LVIS 5.5X33; STENT

Model Number 214049-LVIS

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem Thrombus (2101)

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.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.

Event Description

A user facility medwatch report provided to the manufacturer stated, "there was incomplete expansion of the low-profile visualized intraluminal support (lvis) intraluminal support device which promoted accumulation of thrombus at the dissection site and with inability to traverse the device to affect deployment.".

Manufacturer Narrative

Additional information was received from the microvention sales representative on 12/9/2019, who stated that the physician informed him that the high-risk patient had "terrible" anatomy and it was a difficult case.The physician stated that the patient died "weeks, maybe months" after the procedure and the death was not related to the device.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.

Manufacturer Narrative

Operative procedure notes indicated the patient presented with a left internal occlusive carotid dissection and intracranial occlusive thrombus in the left m1 segment/middle cerebral artery.Planned treatment included mechanical thrombectomy.There was an incomplete expansion of the distal end of the stent, resulting in slow flow.The stent could not be traversed with numerous neurovascular wires, as well as a balloon dilatation system, and integrilin was administered.Clarifying information provided directly by the treating physician to microvention's product safety physician: the treating physician stated that he was not aware that the patient had died, as reported, and none of the patient's medical notes indicate a patient death.He clarified that the lvis was used to treat a left internal carotid artery with a vessel dissection with a previously formed thrombus which occurred prior to the use of the lvis device; the lvis stent did not cause the dissection, but was used to treat it.The stent remains in the patient's carotid artery, partially opened.A2: additional information a3: additional information b2: additional information b7: additional information.

• Brand Name: LVIS 5.5X33
• Type of Device: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9288740
• MDR Text Key: 165373812
• Report Number: 2032493-2019-00264
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429100981
• UDI-Public: (01)00842429100981(11)161213(17)191130(10)16121329M
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2019

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
• Device Operator: Other
• Device Expiration Date: 11/30/2019
• Device Model Number: 214049-LVIS
• Device Catalogue Number: 214049-LVIS
• Device Lot Number: 16121329M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 12/09/2019; 12/09/2019
• Supplement Dates FDA Received: 12/13/2019; 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52 YR