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

Model Number W2-11-6-MVI

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

Patient Problem Ruptured Aneurysm (4436)

Event Date 10/28/2022

Event Type  Death  

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 analysis.Procedural and post procedural reports were not provided but are currently being sought.If obtained, they will be analyzed and findings will be communicated in a supplemental report.Angiographic images were provided and their investigation is currently ongoing.The instructions for use (ifu) identifies aneurysm perforation or rupture and death as potential complications associated with use of the device.

Event Description

It was reported that a patient was treated for an acute basilar tip aneurysm with a web device.The surgeon determined that the first web device chosen was too large, so it was removed and replaced with a smaller web device.Initially, the surgeon had difficulty detaching the device, but was ultimately successful and was happy with the web placement.It was reported that the patient later passed from a re-bleed on an unknown date.There is no indication of product issues or connection to the patient post-procedure death.

Manufacturer Narrative

Following 11/3/22 initial submission, the company reviewed images provided by the customer: image 1: poor quality 3d ct angio of the distal basilar artery, ap projection, showing a medium-sized, wide neck basilar tip aneurysm, with a murphy's tit at its apex.No measurements are on the image.P22-5237 image 2: coronal cta shows the same aneurysm.Height: 9.1 mm, width: 7.6 mm.P22-5237 image 3: axial cta shows the same aneurysm.Two width measurements are shown, each 8.1 mm.P22-5237 image 4: sagittal cta shows the same aneurysm.Height: 8.2 mm.P22-5237 image 5: ap sim & cure image.No measurements of suggested device.These images do not explain or demonstrate the reported sizing or detachment challenges or the reasons for the fatal rebleed.Without the return and physical evaluation of the device, the investigation cannot definitively determine if a product-related condition existed that would have caused or contributed to the reported event.However, the device's risk documentation does not suggest any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.Moreover, a search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the reported event.The company notes that all reported issues that occurred are well-recognized potential complications that are addressed in the product's instructions for use.

• 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: 15889102
• MDR Text Key: 304584458
• Report Number: 2032493-2022-00429
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102480
• UDI-Public: (01)00842429102480(11)200814(17)250731(10)20081412H
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: W2-11-6-MVI
• Device Lot Number: 20081412H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2022
• 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): Death