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

Model Number MV-WB050321

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Numbness (2415); Ischemia Stroke (4418)

Event Date 03/04/2021

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 not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies ischemic stroke and neurologic deficits as potential complications associated with use of the device.

Event Description

It was reported that a web device was implanted in an aneurysm in the right middle cerebral artery (mca).The sidewall of the device was slightly protruding into the m2 interior trunk of the mca, so a stent was placed from the m1 to the m2 segment.The following day, a small lesion of cerebral infarction in the right sensory area was discovered by high signal intensity diffusion weighted imaging.The patient noticed a slight numbness in the left palm, but the symptom was almost resolved on the day of their discharge.No additional treatment was performed.The patient's condition was stated to be "not serious" and "recovering." according to the physician, the infarction and numbness is not attributable to the web device, but is attributable to the procedure.

• 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
• MDR Report Key: 11639136
• MDR Text Key: 244617487
• Report Number: 2032493-2021-00126
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 04987892122309
• UDI-Public: (01)04987892122309(11)200910(17)230831(10)20091015U
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: MV-WB050321
• Device Lot Number: 20091015U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2021
• 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): Other; Required Intervention