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

Model Number MV-WB070421

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 11/30/2021

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the reported 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 thus could not be returned to the manufacturer for evaluation.Fluoroscopic media was not provided.The event could not be confirmed.The instructions for use (ifu) identifies hemorrhage as a potential complication associated with use of the device.

Event Description

It was reported that on (b)(6) 2021, a web device was implanted in an unruptured cerebral aneurysm of the left mca.On the same day, subarachnoid hemorrhage was noted on the same side as the aneurysm.No additional treatment was performed.The patient's condition improved on (b)(6) 2021 and the patient was discharged from the hospital on (b)(6) 2021.Dapt (aspirin and clopidogrel) was started on (b)(6) 2021 after that, clopidogrel was discontinued on (b)(6) 2021, and aspirin was discontinued on (b)(6) 2021.The root cause of the sah is unknown but it was stated that a causal relationship to the device and procedure cannot be ruled out.

Manufacturer Narrative

A search for non-conformances associated with the reported 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 thus could not be returned to the manufacturer for evaluation.Fluoroscopic media was not provided.The event could not be confirmed.The instructions for use (ifu) identifies hemorrhage as a potential complication associated with use of the device.

Event Description

It was reported that on (b)(6) 2021, a web device was implanted in an unruptured cerebral aneurysm of the left mca.On the same day, subarachnoid hemorrhage was noted on the same side as the aneurysm.No additional treatment was performed.The patient's condition improved on (b)(6) 2021 and the patient was discharged from the hospital on (b)(6) 2021.Dapt (aspirin and clopidogrel) was started on (b)(6) 2021 after that, clopidogrel was discontinued on (b)(6) 2021, and aspirin was discontinued on (b)(6) 2021.The root cause of the sah is unknown but it was stated that a causal relationship to the device and procedure cannot be ruled out.

Manufacturer Narrative

New information received via email stated that the sah occured on the same side as the web implantation site.The physician assumed the the sah was caused by the artery stretching while the microcatheter or dac was being advanced to the periphery.No imaging was available.

• 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; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13419311
• MDR Text Key: 285235523
• Report Number: 2032493-2022-00043
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 04987892122378
• UDI-Public: (01)04987892122378(11)200910(17)250831(10)2009101M1
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MV-WB070421
• Device Lot Number: 2009101M1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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): Hospitalization; Other