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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR DEVICES
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MICROVENTION, INC. WEB SL; INTRASACCULAR DEVICES Back to Search Results
Model Number W5-6-4-MVI
Device Problems Device Dislodged or Dislocated (2923); Difficult or Delayed Separation (4044)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2023
Event Type  malfunction  
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 stated to be available for return to the manufacturer but has not yet been returned.The remainder of the device is implanted in the patient and is not accessible for testing.The alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental report will be submitted.
 
Event Description
It was reported that a web device was placed in an aneurysm and repositioned twice before achieving optimal position.A detachment controller was unable to detach the implant after two attempts.The microcatheter was placed against the base of the implant and it would not detach.It was decided to removed the implant, but the implant detached and remained in the aneurysm.The implant moved during the detachment and was in a sub-optimal position, leaving a slight, slow inflow to a side bleb, which the physician expected to clot off.There was no injury or intervention.The patient awoke without any deficit from the procedure.
 
Manufacturer Narrative
The reported complaint is confirmed.The investigation of the returned web system found the implant separated from the delivery system, the black lead wire broken at the distal solder joint, and the heater coil windings stretched.The implant was not returned for evaluation as it remained in the aneurysm as described in the reported event.The device failed continuity and resistance testing due to the damaged lead wire and heater coil windings.However, the heater coil pet was found melted, indicating that the device was activated using a detachment controller during the procedure; therefore, the damage to the heater coil windings and lead wire likely occurred post-activation.The stretched heater coil windings are an indication that the tether could have been caught in between the coil windings and caused the heater coil to stretch when the delivery system was pulled/retracted during the procedure.The physical evaluation of the device could not identify the conditions or circumstances that led to the lead wire damage, but the damage is consistent with the device experiencing forces over specification.The returned detachment controller was found to function as intended and would not have caused or contributed to the reported event.
 
Event Description
It was reported that a web device was placed in an aneurysm and repositioned twice before achieving optimal position.A detachment controller was unable to detach the implant after two attempts.The microcatheter was placed against the base of the implant and it would not detach.It was decided to removed the implant, but the implant detached and remained in the aneurysm.The implant moved during the detachment and was in a sub-optimal position, leaving a slight, slow inflow to a side bleb, which the physician expected to clot off.There was no injury or intervention.The patient awoke without any deficit from the procedure.
 
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Brand Name
WEB SL
Type of Device
INTRASACCULAR DEVICES
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
terrence callahan
35 enterprise
aliso viejo, CA 92656
7142478000
MDR Report Key18315350
MDR Text Key330471856
Report Number2032493-2023-01114
Device Sequence Number1
Product Code OPR
UDI-Device Identifier00842429102145
UDI-Public(01)00842429102145(11)220727(17)270630(10)0000232050
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170032
Number of Events Reported1
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 01/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberW5-6-4-MVI
Device Lot Number0000232050
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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