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

Model Number	7110-0306-3D-A2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural or post procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies coil migration as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during coil embolization of a ruptured left posterior communicating artery aneurysm, an embolization coil implant had a coil tail extend into the parent artery.It then migrated further into the proximal left middle cerebral artery (mca).Integrilin was given as a intravenous bolus, followed by infusion.An intracranial stent was deployed from the proximal left mca into the left internal carotid artery, tacking down the migrated coil loop and crossing the neck of the aneurysm.Check angiography showed appropriate placement of the stent, and lack of thromboembolic complications or platelet aggregates.The patient is reportedly "doing well.".

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 11600581
• Report Number: 2032493-2021-00104
• Device Sequence Number: 14317887
• Product Code: HCG
• UDI-Device Identifier: 00816777025463
• UDI-Public: (01)00816777025463(11)181010(17)230930(10)1810105P6
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

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: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 7110-0306-3D-A2
• Device Lot Number: 1810105P6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/31/2021
• 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: 57 YR
• Patient Weight: 65