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

Model Number 7110-0308-3D-A2

Device Problems Difficult to Remove (1528); Stretched (1601); Detachment of Device or Device Component (2907)

Patient Problems Neurological Deficit/Dysfunction (1982); Perforation of Vessels (2135)

Event Date 02/26/2020

Event Type  Injury  

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 not returned to the manufacturer for evaluation.The root cause cannot be determined.The coil detachment occurred after the aneurysm perforation; therefore, the device malfunction did not cause or contribute to the adverse event.Additionally, it is unknown if the coil or the microcatheter (not a microvention device) perforated the aneurysm.

Event Description

It was reported that treatment was performed for a choroidal aneurysm.During placement of the embolization coil, the aneurysm was perforated.During the attempt to retract the coil, the coil stretched and then detached.Another coil was placed in the aneurysm, which was successful in stopping the extravasation.The detached coil segment was then removed from the patient with a stent retriever.The patient woke up from anesthesia.The patient was reported to have had a stroke, but was slowly improving.

Manufacturer Narrative

Additional information received from the sales representative indicated that the patient presented to the hospital with a subarachnoid hemorrhage.

• Brand Name: HYDROSOFT 3D ADVANCED
• Type of Device: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9892316
• MDR Text Key: 186751990
• Report Number: 2032493-2020-00075
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777025470
• UDI-Public: (01)00816777025470(11)181119(17)231031(10)1811195W6
• Combination Product (y/n): N
• PMA/PMN Number: K080666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Model Number: 7110-0308-3D-A2
• Device Catalogue Number: 7110-0308
• Device Lot Number: 1811195W6
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention