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

Model Number	100208H2HS-V-N
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ischemia Stroke (4418); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance's 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 the delivery pusher was not returned to the manufacturer for analysis.Three fluoroscopic images were provided, which demonstrate a section of coil tail extending from the superior cerebral artery to the vertebral artery.It could not be determined if the coil detached using a detachment controller or from excessive force.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during coil embolization to treat an aneurysm in the superior cerebellar artery (sca), the embolization coil detached during retraction while repositioning.A stent was deployed in the vertebral artery to secure the coil tail to the vessel wall.There was no reported patient injury or sequela.The current condition of the patient is reported to be "stable, good.".
Additional Manufacturer Narrative
Additional information indicated: "the patient had late ischaemic events with stroke in the posterior circulation, very likely related to the requirement to manage the coil tail with a stent.".
Additional Manufacturer Narrative
B2.H10: additional information received.There was a ruptured right superior cerebellar aneurysm.Three coils were used.Two deployed within the aneurysm, but the third detached during manipulation and deployed mostly outside the aneurysm.The patient developed strokes in the cerebllum, pons and occipital attributed to the coil tail/stent.Patient recovering from ventriculoperitoneal (vp) shunt revision procedure.The instructions for use (ifu) identifies stroke, clot formation, and coil misplacement as potential complications associated with use of the device.

• Brand Name: HYDROSOFT HELICAL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11276973
• Report Number: 2032493-2021-00028
• Device Sequence Number: 3416276
• Product Code: HCG
• UDI-Device Identifier: 00811425020173
• UDI-Public: (01)00811425020173(11)191023(17)240930(10)1910235TR
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2021

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: 09/30/2024
• Device Model Number: 100208H2HS-V-N
• Device Catalogue Number: 100208H2HS-V
• Device Lot Number: 1910235TR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 01/26/2021; 05/07/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/23/2021; 06/04/2021
• 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: Life Threatening; Other; Required Intervention