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

Model Number W5-7-S-MVI

Device Problems Retraction Problem (1536); Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2021

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 device was implanted in the patient; therefore, not available for the manufacturer for analysis; however, procedure images were provided.The images were reviewed and showed a web device implanted with a stent being used to support the treatment of the basilar tip aneurysm.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.

Event Description

It was reported that during treatment of a basilar tip embolization, the web could not be withdrawn within the catheter.The web was detached in a non ideal position.A stent was required to support the proximal surface and side (p1) artery.The anatomy was stated to be slightly torturous.The patient was reported to be fine and well.

• Brand Name: WEB SLS
• 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: 12316798
• MDR Text Key: 266366700
• Report Number: 2032493-2021-00326
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102190
• UDI-Public: (01)00842429102190(11)201029(17)250930(10)2010291AA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-7-S-MVI
• Device Lot Number: 2010291AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• 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): Required Intervention