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

Model Number	7110-0256-3D-A2
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	06/19/2020
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 returned to the manufacturer for evaluation.The investigation is ongoing.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during placement of an embolization coil in an aneurysm, the coil unexpectedly detached in the vessel.The detached coil segment was retrieved from the patient with a comaneci device.There was no reported patient injury.
Additional Manufacturer Narrative
All relevant components of the device were returned along with a guide catheter, two microcatheters, a snare device, and a v-grip detachment controller.A portion of the implant was found deployed out of the distal tip of a microcatheter and was initially tangled with the catheters.Once untangled, the implant was found stuck within the microcatheter.The large catheter was smashed.However, the two microcatheters were able to be removed from the large catheter.No notable damage was observed along the two microcatheters.One microcatheter contained a snare device.The other microcatheter contained the v-trak device with the implant deployed outside of its distal tip.An x-ray was performed on the microcatheter with the v-trak device.The entire implant was observed to be stretched within the microcatheter.The proximal end of the implant was observed to be mated with the heater coil of the pusher about 11.9cm from the distal tip of the microcatheter.The body coil of the pusher appeared to be intact.The v-trak device was successfully advanced through the microcatheter until the distal end of the pusher was deployed.The implant was still attached to the pusher.The entire implant was present, as the distal ball of the implant was observed.The implant was found to be severely stretched as a result of excessive tensile or retraction forces.The physical evaluation of the returned components could not identify the exact circumstances that led to this condition, but the excessive stretching is consistent with the implant becoming stuck and subsequently stretched due to retraction or the use of the snare device.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10292688
• Report Number: 2032493-2020-00170
• Device Sequence Number: 14084826
• Product Code: HCG
• UDI-Device Identifier: 00816777025432
• UDI-Public: (01)00816777025432(11)191003(17)240930(10)1910031W6
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2020

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: 09/30/2024
• Device Model Number: 7110-0256-3D-A2
• Device Catalogue Number: 7110-0256
• Device Lot Number: 1910031W6
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/04/2020
• 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: 60 YR