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

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

Patient Problems Stroke/CVA (1770); Thromboembolism (2654)

Event Type  Injury  

Manufacturer Narrative

The device lot number is unknown; therefore, a search for non-conformances associated with the reported part/lot number combination could not be performed.The devices were implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identify thromboemboli and neurological deficits as potential complications associated with use of the device.

Event Description

As reported through the article titled, "a comparison between sc-tof and the cat-dsa for web device management "periprocedural complications were observed in 8 patients.In 5 cases, there were permanent neurologic deficits due to thromboembolism, a result of partial sagging into the perianeurysmal artery.In all patients, thromboembolic complications were observed in the first week after the intervention.

• Brand Name: WEB
• 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: 12292093
• MDR Text Key: 265557256
• Report Number: 2032493-2021-00312
• Device Sequence Number: 1
• Product Code: OPR
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2021
• 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