MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL 10 VTA; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100206H2HS-V-A2
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported through the rage study, a patient with a history of hypertension and hypothyroidism presented with a one day history of headaches and confusion.The patient was found to have diffuse subarachnoid hemorrhage with an anterior communicating artery aneurysm on cta.The patient underwent endovascular, balloon assisted coil embolization of an anterior communicating artery aneurysm with excellent obliteration of aneurysm, consistent with raymond roy grade 1.The procedure was complicated by intraprocedural rupture.Reportedly, following insertion of a hydroframe 5mm x 10cm embolization coil implant (see mdr 2032493-2021-00502) , the coil was noted to be partially protruding through the aneurysm wall into the subarachnoid space.A transform balloon was inflated and a second coil was rapidly placed without evidence of extravasation on the following injection.The last coil implant partially herniated into the anterior communicating artery, but without evidence of surrounding thrombosis or flow limitation.Dyna ct showed evidence of new hemorrhage, however, with mild hydrocephalus necessitating evd insertion.
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 investigation.The alleged event and product issue could not be confirmed.

• Brand Name: HYDROSOFT HELICAL 10 VTA
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13015994
• Report Number: 2032493-2021-00503
• Device Sequence Number: 4803663
• Product Code: HCG
• UDI-Device Identifier: 00816777022899
• UDI-Public: (01)00816777022899(11)181115(17)231031(10)1811155PR
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070656
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2021

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: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 100206H2HS-V-A2
• Device Catalogue Number: 100206H2HS-V
• Device Lot Number: 1811155PR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male