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

Model Number 100151HS-V-A2

Device Problem Activation Failure (3270)

Patient Problems Convulsion/Seizure (4406); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Event Description

It was reported that after positioning of the embolization coil, the coil did not detach despite using multiple detachment controllers.Reportedly, the physician elected to leave the pusher with coil still attached in the patient.At the completion of the procedure, the patient was awake with no neurological damage and with a mild subdural hematoma.

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 the delivery system was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

Manufacturer Narrative

Additional information about the procedure was received via email.The coil was stuck inside the packing of the previous coils that were placed.When the physician tried to pull, the entire pack of coils moved together.The treatment was not an aneurysm but an avm.The distal part of the pusher was left inside the coil pack.The had seizures a few hours after the procedure so the physician gave the patient a medication for it.No plans for additional intervention/treatment as the avm looks completely closed.The location of the avm nidus was in the temporal lobe.Patient current status is fine with no neurological damage.Physician performed a mri that showed a significant magnetic artifact, generated probably from the thread that was left inside the patient after the procedure.

Manufacturer Narrative

Three t2 axial brain mri images were provided via email, taken at the level of the basal ganglia.These show a large magnetic artifact in the right temporal lobe, likely from the piece of coil pusher that was left in the patient.The artifact likely obscures the avm that is described in the complaint report.The cause for the problem encountered with the coils is not apparent.The subdural hematoma described in the complaint report is not apparent in the images.Without the return and physical evaluation of the device, the investigation could not determine if a condition existed that would have caused or contributed to the reported event.

• Brand Name: HYPERSOFT-AV
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13054362
• MDR Text Key: 285241346
• Report Number: 2032493-2021-00511
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777020536
• UDI-Public: (01)00816777020536(11)190920(17)240831(10)1909205WH
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K091641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100151HS-V-A2
• Device Lot Number: 1909205WH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2019
• 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 Age: 67 YR
• Patient Sex: Male