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

Model Number MV-00619HHTA

Device Problems Difficult or Delayed Positioning (1157); Unraveled Material (1664); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2021

Event Type  Injury  

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 returned to the manufacturer for evaluation.The investigation is ongoing.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.

Event Description

It was reported that during treatment of the an aneurysm of the internal carotid-posterior communicating artery, an embolization implant coil stretched.A jailing technique with a stent was used and a portion of the coil was protruding through the struts of the stent.While attempting to insert the coil segment by pushing and pulling the coil several times, the coil became unraveled.When the pusher was withdrawn, the coil was unintentionally detached at the detachment point.Then, the microcatheter was withdrawn and the coil was left in the parent vessel.The coil was successfully removed from the patient using a snare.It was reported that there was no health damage to the patient.

Manufacturer Narrative

H11 - corrections.H10 - the device was discarded at the user facility and not returned to the manufacturer for analysis.The alleged product issue could not be confirmed.Additionally, the ifu identifies difficult coil detachment as a potential complication associated with use of the device.

• Brand Name: HYDROSOFT 3D ADVANCED
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12155827
• MDR Text Key: 264388426
• Report Number: 2032493-2021-00278
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04987892070334
• UDI-Public: (01)04987892070334(11)191009(17)240930(10)1910095X6
• Combination Product (y/n): N
• PMA/PMN Number: K103758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-00619HHTA
• Device Lot Number: 1910095X6
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR