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

Model Number FG29050-001

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

Patient Problem Aneurysm (1708)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances 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 implanted in the patient and not returned to the manufacturer for evaluation.Procedural images were not provided for review; therefore, the alleged product issue cannot be confirmed.

Event Description

It was reported that a patient enrolled in the clever study received treatment on (b)(6) 2019.The patient received embolization treatment for an unruptured aneurysm located in the anterior communicating artery complex with a web 17 sls.The angiographic result at the end of the procedure is residual aneurysm (raymond iii).The patient was discharged on (b)(6) 2019 with the clinical evaluation results as mrs grade 0.Four months post procedure, the patient complained having headaches, started since the index procedure.Reportedly, in the year 2020, the patient had a post procedure complication of increased dementia.No additional treatment or intervention was taken in that regards.The patient medical history included beginning of dementia.The event relatedness to the device is unknown.

• 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: 12102183
• MDR Text Key: 259655881
• Report Number: 2032493-2021-00263
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00854111006181
• UDI-Public: (01)00854111006181(11)180823(17)210923(10)18082306
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2021
• Device Model Number: FG29050-001
• Device Lot Number: 18082306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2018
• 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
• Patient Age: 80 YR