MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number WEB SL

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

Patient Problem Ruptured Aneurysm (4436)

Event Date 03/31/2022

Event Type  Injury  

Event Description

It was reported that a (b)(6) (copd) patient underwent a procedure to treat a small middle cerebral artery (mca) aneurysm with a microvention (mv) web sl 5 x 3 stent and suffered a ruptured mca aneurysm, requiring surgical intervention.During the procedure, a mv web sl 4 x 3 was deployed and removed, as it was too small for the aneurysm.Thereafter, a web sl 5 x 3 was deployed and would not enter the mv via 17 catheter.A second web sl 5 x 3 stent was deployed and the small mca aneurysm ruptured.The web sl 5 x 3 was removed, and 2 unknown coils were used to treat the aneurysm.A scepter 4 x10 balloon catheter was used after the unknown coils were deployed.General anesthesia was not administered to the patient.The patient is reported to be stable.

Manufacturer Narrative

The information received is part of the product investigation which is still ongoing.When the product investigation is completed, a supplemental 3500a will be submitted.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14139442
• MDR Text Key: 289500628
• Report Number: 2032493-2022-00155
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110850
• UDI-Public: (01)00842429110850(11)211124(17)241031(10)0000127996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WEB SL
• Device Catalogue Number: W5-5-3-MVI-3
• Device Lot Number: 0000127996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: MICROVENTION SCEPTER 4 X10 BALLOON CATHETER; MICROVENTION VIA 17 CATHETER; MICROVENTION WEB SL 4 X 3 STENT; MICROVENTION WEB SL 5 X 3 STENT
• Patient Age: 65 YR
• Patient Sex: Female