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

Model Number UNKNOWN

Device Problem Positioning Problem (3009)

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

Event Date 10/12/2018

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided; therefore, a review of device history record (dhr) could not be performed.The device was not returned for evaluation; therefore, the product analysis could not be performed and the alleged product issue cannot be verified.If additional new information is received, microvention inc.Will submit a supplemental report.The instructions for use (ifu) identifies difficult coil detachment as potential complications associated with use of the device.

Event Description

As reported in the rage clinical study, the patient was being treated for a basilar tip aneurysm measuring midline, height: 5.60, width: 4.70, depth: 5.20, neck size: 4.00.Dome to neck ratio: 1.18.As the first centimeter of the 6th coil was being deployed in the aneurysm, the microcatheter tip displaced from the aneurysm sac back into the basilar apex.A loop of a previously detached coil was also noted to shift position and displaced into the p1 segment of the pca.The 6th coil was uneventfully removed from the patient along with the microcatheter.Integrilin medication was administered and issue resolved without sequelae.

Manufacturer Narrative

Additional information received.The patient presented with a good neurological grade, small aneurysmal subarachnoid hemorrhage from an acutely ruptured basilar tip aneurysm.The patient was undergoing endovascular embolization of this aneurysm.During the coiling of the aneurysm, five coils were uneventfully positioned in the aneurysm sack and uneventfully detached.The aneurysm was then explored with a sixth coil, however as the first centimeter of this sixth coil was advanced into the aneurysm it displaced the microcatheter tip (and a tiny loop of a previously detached coil) into the basilar apex.The displacement of the aneurysm tip from the aneurysm sac was unintentional.The angiographic appearance of the migrated tiny loop of coil strongly suggested that it was safer to leave the tiny loop of coil in that position, rather than to try to reposition the coil or tack it down with a stent.The decision not to further manipulate the coil appears to be the correct decision, as the patient did not have any adverse effects from the position of the coil.There was no stroke.The coil loop w as sub-occlusive.In addition, there was collateral supply to the p1 segment of the left pca from the left posterior communicating artery.There was no additional mechanical intervention to deal with the loop of coil encroaching on the parent artery.Pharmacologic intervention included administration of integrilin, followed by dual antiplatelet therapy with aspirin and plavix.At some point after discharge the patient was uneventfully converted to antiplatelet monotherapy.The patient is alive and well.The patient remained neurologically intact following this procedure and hasn't had any ischemic stroke, hemorrhagic stroke, or neurological deficit.Summary of investigation: visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.A detailed review of provided operative report has been completed.Data review indicates that a patient was treated for an acute aneurysmal subarachnoid hemorrhage.Coil embolization of a ruptured basilar tip aneurysm was performed utilizing a total of five hydroframe and hydrofoil coils.A sixth coil was attempted to be placed into the aneurysm, it displaced from the microcatheter tip back into the basilar apex.A loop of a previously deploy coil was noted to shift position.The six coil was uneventfully withdrawn.Investigation conclusion the reported event is non-verifiable.A detailed review of provided operative report has been completed.No device malfunction was reported.A coil device reported as having shifted was associated with the performance of the procedure, packing of the aneurysm and not associated with a device malfunction.Angiography demonstrated excellent post procedure blood flow to the left posterior cerebral artery with stable complete occlusion of the basilar tip aneurysm.No patient injury or harm was reported.Patient was reported as awake and neurologically intact postoperatively.Without the return and physical evaluation of the device, the investigation cannot determine if a condition exists that would have caused on contributed to the reported event.

• Brand Name: HYDROSOFT-3D-AV
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICRVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92694 ; 7142478000
• MDR Report Key: 16781925
• MDR Text Key: 313706572
• Report Number: 2032493-2023-00680
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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