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

Model Number W2-9-4

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/06/2024

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 returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Event Description

It was reported that during a web embolization procedure, the device did not take the proper shape when it was advanced through a siphon, which was reported to be tortuous, to be placed into the aneurysm.When the physician attempted to re-sheath and redeploy the web, it would not open in the same exact position.During removal, the web would not re-sheath.A catheter was advanced to the aneurysm neck, and the web was forcibly pulled back into the catheter.The patient had collaterals forming and little deficits suspected.The physician suspected that the patient may had a minor stroke from either a clot or damage to vessel due to aggressively trying to re-sheath device.The patient was administered aggrastat interprocedurally.After a few days, the patient was reported to be ¿perfectly well¿ and was discharged.

Manufacturer Narrative

Correction : h1 was changed from malfunction to serious injury.The investigation of the returned web system found the web implant to be in good shape, and within dimensional specification upon receipt.Furthermore, the web implant fully opened upon deployment during functional testing.The returned microcatheter was found wrinkled between 20cm to 30cm from the distal tip and flattened at 1cm from the distal tip, which may have caused or contributed to the alleged advancement and re-sheathing difficulty issue as described in the reported event.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.

Event Description

See h.10.

• 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: 18792210
• MDR Text Key: 336399758
• Report Number: 2032493-2024-00167
• Device Sequence Number: 1
• Product Code: OPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W2-9-4
• Device Lot Number: 0000160171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2022
• 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
• Patient Sex: Female