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

Model Number	7110-0254
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The coil remains implanted in the patient and the remainder of the device was discarded at the user facility; therefore, a product evaluation could not be performed.The root cause is unknown.The instructions for use (ifu) identifies coil migration and misplacement as potential complications associated with use of the device.
Event or Problem Description
It was reported that during an embolization treatment for a ruptured aneurysm, the coil was implanted.Ct images taken 3 days later showed the coil had dislodged and migrated downstream to the right distal inferior division.No intervention was performed for the migrated coil.The initial treatment site was re-coiled with stent assistance the day after the ct was performed.The patient was discharged and is reported to be alert and oriented, and there are no neurologic deficits.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7721281
• Report Number: 2032493-2018-00146
• Device Sequence Number: 1065134
• Product Code: HCG
• UDI-Device Identifier: 00816777025425
• UDI-Public: (01)00816777025425(11)170607(17)220531(10)1706071W9
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2022
• Device Model Number: 7110-0254
• Device Lot Number: 1706071W9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 99