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

Model Number W5-3.5-2-MVI

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

Patient Problems Headache (1880); Paralysis (1997); Vasoconstriction (2126); Speech Disorder (4415)

Event Date 09/03/2022

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 is not available to return to the manufacturer for analysis, and procedure images were not provided.Therefore, the alleged product issue cannot be confirmed.If additional information is received, microvention, inc.Will submit a supplemental report.The instructions for use (ifu) identifies vasospasm, headache, and neurologic deficits as potential complications associated with use of the device.

Event Description

It was reported that the web device was successfully implanted on (b)(6) 2022 to treat a subarachnoid hemorrhage (sah), anterior communicating artery (acom) aneurysm.During hospital stay, vasospasm on the left side occurred, which was treated with antispasmodics.The patient was discharged with light motoric aphasia.Reportedly, 1-2 weeks post procedure, the patient's condition worsened with progressive aphasia, right side hemiparesis, headache, and hypertonia.In the hospital, progressive cerebral enrichment was administered for suspected nice (non-ischemic cerebral enhancing).Treatment with methylprednisolone showed significant improvement.Currently, the patient's condition was described as progressive symptoms during lowering of the prednisolone dose.The patient is put on follow-up.

Manufacturer Narrative

Additional information received indicating no pre-existing conditions known which led to current patient condition.Unknown if patient was compliant with any dapt medicines post procedure.

Manufacturer Narrative

Additional information: h10 (image review).Four images were supplied.All four are from the same projection of an oblique left ica angiogram and are not dated.There are no measurements.Three are at different arterial phases of the subtracted dsa, and one has the superimposed bony background.They show a web in an occluded acom aneurysm; the web is adequately positioned.There are no images of the aneurysm before treatment.There are mild irregularities of the left a1, acom, and of the proximal bilateral a2s - these are in keeping with mild vasospasm secondary to the sah.There are no images that demonstrate the more severe vasospasm that is described to have occurred later on.The vasospasm on these images and the vasospasm that occurred subsequently are not related to the web procedure but rather to the sah, which is a known common cause of vasospasm.Without the return and physical evaluation of the device, the investigation cannot determine if a condition exists that would have caused or contributed to the reported event.

• 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: 15906404
• MDR Text Key: 304717182
• Report Number: 2032493-2022-00539
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102039
• UDI-Public: (01)00842429102039(11)220328(17)270228(10)0000171932
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: W5-3.5-2-MVI
• Device Lot Number: 0000171932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2022
• 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