MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL 17 SINGLE LAYER W5-4-3; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number FG29040-030

Device Problem Activation Failure (3270)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/14/2020

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 returned to the manufacturer for evaluation.The investigation is currently underway.The instructions for use identifies parent artery occlusion and clot formation as potential complications associated with use of the device.

Event Description

It was reported that the web would not expand in the middle during deployment.After removal of the web, clot was identified and iv integrilin was administered to the patient.There was no reported sequela.The patient's current outcome was reported as "no deficit.".

Manufacturer Narrative

Photographs provided by the customer were reviewed by a product safety physician.The images demonstrated a web that was constricted in the mid portion, consistent with the reported event details.The inspection of the returned web device confirmed the implant did not have the correct shape; however, dried blood was found on the implant, and once removed, the implant regained the correct shape.

• Brand Name: WEB SL 17 SINGLE LAYER W5-4-3
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10681399
• MDR Text Key: 211424181
• Report Number: 2032493-2020-00285
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00854111006259
• UDI-Public: (01)00854111006259(11)190701(17)220730(10)19070117
• Combination Product (y/n): N
• PMA/PMN Number: P170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/30/2022
• Device Model Number: FG29040-030
• Device Lot Number: 19070117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention