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

Model Number UNKNOWN

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

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

The lot numbers were not provided; therefore, a search for production-related ncrs could not be performed.The devices were implanted in the patient and were not returned to the manufacturer for evaluation.Additionally, procedural images were not provided; therefore, the reported events cannot be confirmed.The instructions for use (ifu) identifies thromboemboli as a potential complication associated with use of the device.

Event Description

As reported through the article titled, "endovascular treatment of small and very small intracranial aneurysms with a web device," post successful intracranial aneurysm treatment with either a sl 3 or a sl 3.5 web device (dates unknown), 4 patients were reported to have developed thromboembolic complications, of which 3 were intraoperative thromboembolism.Of those 3, complete recanization was achieved during the final angiography in 2 patients after intra-arterial abciximab injection.In the third case, owing to the excellent leptomeningeal collateral circulation, it was decided not to perform any endovascular treatment and no deficit was observed after the intervention.

• 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 drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12334178
• MDR Text Key: 267038295
• Report Number: 2032493-2021-00352
• Device Sequence Number: 1
• Product Code: OPR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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