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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC MICROPLEX HYPERSOFT 3D VT; EMBOLIZATION COIL
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MICROVENTION, INC MICROPLEX HYPERSOFT 3D VT; EMBOLIZATION COIL Back to Search Results
Model Number 100256HS3D-V
Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2019
Event Type  Injury  
Manufacturer Narrative
The lot number was provided.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.The investigation is currently underway.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
 
Event Description
It was reported fthat an embolization coil detached prematruely in the microcatheter during advancement.The embolization coil was removed with a snare device.There was no reported injury to the patient.
 
Manufacturer Narrative
The lot number was provided.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.Only the pusher was returned for analysis.The implant, microcatheter, packaging, and introducer were not returned.The implant and microcatheter were not returned, preventing complete analysis of the reported complaint.The pusher was found to be bent in multiple locations throughout the hypotube.It cannot be determined if the damage was the result of handling during the procedure or the result of returned shipment activities.The distal end of the pusher was also found to be offset and kinked in multiple locations near the platinum coil marker and the attachment locations.Again, it cannot be determined if the damage was the result of handling during the procedure or the result of returned shipment activities.The heater coil was found to be in good condition and without damage.The pusher was found to register green lights and have a resistance measurement within spec.The monofilament was extracted to determine the tensile break profile.The monofilament profile was found to represent a mushroom shape, historically indicating thermal detachment was enacted.Based on the investigation findings and available information, the reported complaint is confirmed.The pusher was returned without the implant attached.The reported complaint states that the detachment occurred within the microcatheter.The microcatheter and implant are considered critical to the root cause analysis.The root cause of the detachment cannot be identified based on the supplied information.Though it cannot be confirmed, the profile of the monofilament is typically the result of a correctly detached implant via a v-grip.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report or the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
 
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Brand Name
MICROPLEX HYPERSOFT 3D VT
Type of Device
EMBOLIZATION COIL
Manufacturer (Section D)
MICROVENTION, INC
35 enterprise drive
aliso viejo CA 92656
MDR Report Key9386474
MDR Text Key168436437
Report Number2032493-2019-00277
Device Sequence Number1
Product Code HCG
UDI-Device Identifier00816777021069
UDI-Public(01)00816777021069(11)181116(17)231031(10)1811165WT
Combination Product (y/n)N
PMA/PMN Number
K131948
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2023
Device Model Number100256HS3D-V
Device Lot Number1811165WT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2019
Date Manufacturer Received11/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age55 YR
Patient Weight70
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