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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL 21 SINGLE LAYER; INTRASACCULAR DEVICES
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MICROVENTION, INC. WEB SL 21 SINGLE LAYER; INTRASACCULAR DEVICES Back to Search Results
Model Number W4-7-3-CN
Device Problem Premature Separation (4045)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/24/2023
Event Type  malfunction  
Event Description
It was reported that during treatment of an aneurysm, a web device detached unexpectedly after placement in an aneurysm.The device was entirely within the treatment location.There was no injury or intervention.The patient is in good condition.
 
Manufacturer Narrative
The lot number was not provided; therefore, the device history records could not be reviewed and a lot history trending review could not be performed.A portion of the device was returned to the manufacturer for evaluation.The investigation is currently ongoing.
 
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.Returned items: delivery system (pusher), controller.Non-returned items: introducer, implant web ,microcatheter, dispenser hoop.The visual analysis of the returned items found the implant to be separated from delivery system after controller activation and not returned.Tested the returned device with an in-house and returned controller and gave green lights.The delivery system resistance was measured to be 72.1 (spec= 66-78), which is within specifications.The heater coil section was dissected to investigate any obstruction that could possibly prevent the implant from detaching, and the heater coil was found to be in good condition with signs of activation.Furthermore, the implant was not returned so the condition of the tether is unknown.The reported complaint is non-verifiable.The investigation of the returned web system found the implant to be detached with signs of heater coil activation.The issue of "automatically detaching" could not be confirmed with the condition the web device was found during the investigation.The investigation of the returned web device did not find any other damage or anomaly that would have caused or contributed to the reported complaint.H11 -corrections.Part and lot number received via email correspondence.Updates made to following sections: d1, d4, h4.
 
Event Description
It was reported that during treatment of an aneurysm, a web device detached unexpectedly after placement in an aneurysm.The device was entirely within the treatment location.There was no injury or intervention.The patient is in good condition.
 
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Brand Name
WEB SL 21 SINGLE LAYER
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 Key17219760
MDR Text Key318043044
Report Number2032493-2023-00820
Device Sequence Number1
Product Code OPR
UDI-Device Identifier00842429113806
UDI-Public(01)00842429113806(11)211130(17)251031(10)0000127999
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 06/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberW4-7-3-CN
Device Lot Number0000127999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2021
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 SexMale
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