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

Model Number 213025-LVIS-D-PMA

Device Problem Activation Failure (3270)

Patient Problems Extravasation (1842); Hemorrhage/Bleeding (1888); Ischemia (1942); Rupture (2208); Cerebral Edema (4403)

Event Date 09/12/2021

Event Type  Injury  

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 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
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12616271
• MDR Text Key: 275937149
• Report Number: 2032493-2021-00406
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00842429100950
• UDI-Public: (01)00842429100950(11)201007(17)230930(10)201007557
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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): Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 79