MAUDE Adverse Event Report: MICROVENTION, INC. LVIS 5.5X30; INTRALUMINAL SUPPORT DEVICE

Model Number	214035-LVIS
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2019
Type of Reportable Event	Malfunction
Additional 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 stent remains implanted and the delivery system was not returned to the manufacturer, therefore, a product evaluation could not be performed.The root cause could not be determined.
Event or Problem Description
It was reported that treatment was performed for an internal carotid artery dissection.After mechanical thrombectomy with a stent retriever was completed, the lvis stent was deployed; however, it did not fully open at the distal end.An effort was made to open the stent further with the wire, but it was not successful.Blood flow was present in the internal carotid artery where the stent was placed.There was no reported adverse clinical consequence to the patient.

• Brand Name: LVIS 5.5X30
• Common Device Name: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9613543
• Report Number: 2032493-2020-00013
• Device Sequence Number: 14137737
• Product Code: QCA
• UDI-Device Identifier: 00842429100974
• UDI-Public: (01)00842429100974(11)180619(17)210531(10)18061953E
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2021
• Device Model Number: 214035-LVIS
• Device Catalogue Number: 214035-LVIS
• Device Lot Number: 18061953E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2019
• Initial Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR