MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT 3D ADVANCED; EMBOLIZATION COIL

Model Number	8410-0515
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device was not returned to the manufacturer; therefore, a product analysis could not be performed.The root cause is unknown.
Event or Problem Description
It was reported that during deployment of the coil, the pusher broke.The pusher was successfully removed with a snare and stent retriever device.There was no reported patient injury.The patient was reported to be fine.
Additional Manufacturer Narrative
The device was not returned, preventing analysis of the physical component failure modes.Multiple fluoroscopic images were provided by the facility in place of the device.Returned images display the pusher/implant in a small format limiting investigation.Images appear to display an intact pusher, with something protruding from its distal end.It cannot be determined whether or not it is foreign material, pusher coils, or implant coils/mono.The condition of the pusher also cannot be properly evaluated through the images.Another image displays a stretched and broken implant.The image appears to contain the marker band with an elongated coil.The condition of the coil and sustained damage cannot be definitively stated.No causation for the reported complaint can be properly identified from the returned images.Images did not provide enough clarity to perform a root cause analysis.Based on the investigation findings and the available information, the reported complaint could not be verified, as the pusher appeared intact.As a result, the root cause of the failure or the product's involvement in the adverse event could not be determined.

• Brand Name: HYPERSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7940149
• Report Number: 2032493-2018-00210
• Device Sequence Number: 2014592
• Product Code: HCG
• UDI-Device Identifier: 00816777021328
• UDI-Public: (01)00816777021328(11)171127(17)221031(10)1711271W5
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 8410-0515
• Device Lot Number: 1711271W5
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention