MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-10-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 100930HFIL-V-A2

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)

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

Event Date 03/24/2022

Event Type  Injury  

Event Description

It was reported that during an embolization treatment of a ruptured giant acom aneurysm (12mm), the second coil was a hydrofill 9x30.The coil was pushed through a prowler 14 microcatheter.Approximately 50% of the coil was inside the aneurysm and resistance was encountered.It was decided to withdraw the coil.During the withdraw maneuver, the coil detached from the delivery pusher partially within the aneurysm and the microcatheter.The coil was successfully removed using a snare over the transfemoral sheath.Additional coils were place with good result.The patient was reported to be intubated on icu.

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 discarded by user facility and not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed at this time.The instructions for use (ifu) identifies premature coil detachment as potential complication a associated with use of the device.

• Brand Name: HYDROFRAME-10-AV
• Type of Device: 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: 14094804
• MDR Text Key: 289207742
• Report Number: 2032493-2022-00153
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777023315
• UDI-Public: (01)00816777023315(11)201106(17)251031(10)2011061W5
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100930HFIL-V-A2
• Device Catalogue Number: 100930HFIL-V
• Device Lot Number: 2011061W5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention