MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT 3D-AV; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number 100408HS3D-V-A2

Device Problems Stretched (1601); Premature Separation (4045)

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

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with the reported part and lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.The device was reported available for return for analysis, but has not yet been received and procedure images not provided.Therefore, the alleged product issue cannot be confirmed at this time.If the device or additional information is received, a supplemental report will be submitted.

Event Description

It was reported that the embolization coil was used in the treatment of an anterior communicating (acom) aneurysm.During deployment, there was some resistance and the coil stretched and unintentionally detached - half in vessel and half in the microcatheter.The coil along with the microcatheter were removed from the patient.Other coils were used to completer the procedure.There was no report of harm or injury to the patient, who was stable.

• Brand Name: HYPERSOFT 3D-AV
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; 35 enerprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18857484
• MDR Text Key: 337795333
• Report Number: 2032493-2024-00199
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777021120
• UDI-Public: (01)00816777021120(11)230330(17)280229(10)0000343664
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131948
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100408HS3D-V-A2
• Device Lot Number: 0000343664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• 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
• Treatment: ECHELON 10 MICROCATHETER (MEDTRONIC)