MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFILL 10 ADVANCED; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	7310-0720
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2020
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 underway.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that stent-assisted coiling was performed for a large aneurysm in a tortuous vessel.After several coils had been placed, the embolization coil could not fit entirely in the aneurysm.After 6-7 minutes of coil retraction and advancement attempts, 1:1 movement was lost.During attempted coil removal, the coil stretched.A gooseneck snare was used to assist with coil removal and the coil detached.The implant coil was left in place with some coil extending outside the aneurysm and the patient was put on dual antiplatelet/asa therapy post-procedure.There was no reported patient injury.
Additional Manufacturer Narrative
The implant was not returned with the device.The pusher was broken into multiple pieces.The proximal end of the pusher was not returned for analysis.The pusher appeared to have been cut prior to return.A portion of the pusher was returned outside of the microcatheter and had sustained kinks and various forms of damage.Sections of the body coil were stretched and in some portions was stretched to the point of having no coil shape.The microcatheter was returned and had also been cut into multiple sections prior to return, preventing detailed analysis.The distal end of the microcatheter had a strand of the body coil exiting the end and forming a wire mass.The microcatheter was found to be pinched in multiple locations, preventing advancement and retraction in the distal end.Based on the investigation findings and available information, the reported complaint is non-verifiable.The implant was not returned, preventing detailed investigation into the reported complaint.Additionally, the microcatheter and pusher were cut prior to return, limiting the ability to simulate the user experience.Severe damage was present on the device prior to return.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: HYDROFILL 10 ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9862431
• Report Number: 2032493-2020-00069
• Device Sequence Number: 16777594
• Product Code: HCG
• UDI-Device Identifier: 00816777023421
• UDI-Public: (01)00816777023421(11)191001(17)240930(10)1910011W5
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112226
• 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: 09/30/2024
• Device Model Number: 7310-0720
• Device Lot Number: 1910011W5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/08/2020
• 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