MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D ADVANCED; VASCULAR EMBOLIZATION DEVICE

Model Number	7110-0310-3D-A2
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Additional 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 not returned to the manufacturer for analysis.The root cause could not be determined.The instructions for use (ifu) identifies stretching as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that treatment was performed on a partially thrombosed p-com aneurysm.After placement of the embolization coil, the coil could not be detached with three different detachment controllers or a 9-volt battery.During the attempt to remove the coil, the coil stretched.The coil was broken off and tacked against the vessel wall with three (3) stents.Approximately 1 cm of implant coil extended into the p-com and another 6 cm of stretched coils backed down into the cavernous segment.There was no reported patient injury or clinical sequela.
Additional Manufacturer Narrative
A user facility medwatch (ref # 1100780000-2020-8002) was received on 7/20/20, which indicated the aneurysm being treated was unruptured.The patient was placed on blood thinners, post-procedure.Additional information: (a2, a3, a4, a6, b7).

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9862350
• Report Number: 2032493-2020-00070
• Device Sequence Number: 2533891
• Product Code: KRD
• UDI-Device Identifier: 00816777025487
• UDI-Public: (01)00816777025487(11)190206(17)240131(10)1902061W6
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 7110-0310-3D-A2
• Device Catalogue Number: 7110-0310
• Device Lot Number: 1902061W6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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
• Patient Age: 75 YR
• Patient Weight: 155