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

Model Number	213025-LVIS-D-PMA
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Extravasation (1842); Hemorrhage/Blood Loss/Bleeding (1888); Ischemia (1942); Rupture (2208); Cerebral Edema (4403)
Date of Event	09/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance 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 implanted in the patient and the delivery system was not returned to the manufacturer for analysis.Procedural or post procedural images were not provided; therefore, the alleged event and product issue cannot be confirmed.If additional images and information is received at a later date, the investigation will be reopened and a supplemental report will be submitted.The instructions for use (ifu) identifies dissection of the vessel(s), hemorrhaging, ischemia, and stroke as potential complications associated with use of the device.
Event or Problem Description
It was reported that an lvis d stent was implanted to treat a ruptured basilar tip aneurysm.After deploying the stent, the basilar tip aneurysm was coiled successfully.An angiogram was then performed, which showed the right end of lvis stent in the pca not fully deployed and that the right pca was occluded.A scepter xc was advanced under fluoroscopy and inflated.An angiogram performed post inflation showed a pca rupture with extravasation.The right pca was coiled to address the hemorrhage.Afterwards, an angiogram showed limited flow in the basilar artery and brain edema.The patient is in critical condition and intubated.The device associated with this event was used during the same procedure referenced in mfr.Report # 2032493-2021-00414.

• Brand Name: LVIS D
• Common Device Name: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12616271
• Report Number: 2032493-2021-00406
• Device Sequence Number: 19150145
• Product Code: NJE
• UDI-Device Identifier: 00842429100950
• UDI-Public: (01)00842429100950(11)201007(17)230930(10)201007557
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P170013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 213025-LVIS-D-PMA
• Device Catalogue Number: 213025-LVIS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 10/12/2021
• 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: Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 79