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

Model Number	7110-0208
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	12/09/2019
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 has been returned to the manufacturer.The investigation is currently underway.
Event or Problem Description
It was reported that coil embolization treatment was initially performed on a middle meningeal artery on (b)(6) 2019.Approximately four months later on (b)(6) 2019, a follow-up cta demonstrated a metal wire in the internal carotid artery (ica).A second procedure was performed on (b)(6) 2019 to remove the wire from the ica with a stent retriever.The patient's current status is reported to be "normal.".
Additional Manufacturer Narrative
An operative report and fluoroscopic images were provided along with the implant coil.The implant was returned in 3 partial sections, although photos provided by the customer showed 4.The wire diameter was measured and found the filar diameter for the coil in the event were within specifications.The implant coil was stretched, and a partial section of the implant had gel attached to it.The pusher was not returned for evaluation.According a photo from the customer, the biggest section removed was not returned for evaluation.The fluoroscopic images and operative report were reviewed by the product safety physician.The images displayed a stretched filament that is highly consistent with the reported events and and a stretched, retained coil.The investigation of the returned components, as well as the customer supplied images, determined the information available is consistent with a stretched implant coil.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 tensile forces over specification during maneuvering or placement of the coil; however, the root cause could not be determined.Excessively stretched coil filaments may be difficult to visualize under normal fluoroscopy.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9567167
• Report Number: 2032493-2020-00004
• Device Sequence Number: 2133434
• Product Code: HCG
• UDI-Device Identifier: 00816777025401
• UDI-Public: (01)00816777025401(11)190619(17)240531(10)1906191W6
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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: 12/31/2023
• Device Model Number: 7110-0208
• Device Catalogue Number: 7110-0208
• Device Lot Number: 1906191W6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 01/16/2020
• 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: 80 YR