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

Model Number	45-752039
Medical Device Problem Codes	Difficult to Remove (1528); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
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 pusher, implant, and associated v-grip were returned for analysis.Investigation into the returned device found the pusher to be damaged in multiple locations.Numerous bends were noted on the hypotube.A single bend was noted at the e2 epoxy joint.The body coil transition was found to be broken, exposing the internal lead wires.The distal end of the pusher was found to be intact and the implant still attached.The resistance of the pusher was found to be within specification.The corresponding v-grip was tested and passed the pretest.Detachment of the implant was successful on the first attempt.No anomalies were noted on the v-grip.As noted in the complaint, the implant was stretched just distal of the marker band, which occurred during retraction.The timing of the occurrence of the damage could not be confirmed.It could not be determined if the damage was the result of handling during the procedure or the result of returned shipping activities.Based on the investigation findings and available information, the reported complaint is unconfirmed.The implant was successfully detached on the first attempt.The causation for the damage to the pusher could not be determined, but is suspected to be the result of returned shipping activities.The instructions for use (ifu) identifies difficult coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that balloon-assisted coil embolization was attempted as treatment for a ruptured, wide-necked right posterior communicating artery (p-com) aneurysm.After positioning the 3rd coil in the aneurysm, the coil would not detach.The coil was withdrawn and re-advanced to attempt another detachment, without success.The coil was then withdrawn into the microcatheter and the entire system was removed together.During the removal of the system, the previously placed coils prolapsed into the right internal carotid artery.Additional coils were then placed in the aneurysm through a new microcatheter; however, the prolapsed coils could not be pushed back into the aneurysm and a stent was implanted in the parent artery.There was no reported patient injury as a result.The patient was reported to be stable and did well, post-procedure.

• 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: 9578403
• Report Number: 2032493-2020-00007
• Device Sequence Number: 3042406
• Product Code: HCG
• UDI-Device Identifier: 00816777025470
• UDI-Public: (01)00816777025470(11)190226(17)240131(10)1902261W6
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153594
• 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
• Report Date (Section B): 12/11/2019

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: 01/31/2024
• Device Model Number: 45-752039
• Device Catalogue Number: 7110-0308
• Device Lot Number: 1907045J2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/10/2020
• 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