MAUDE Adverse Event Report: MICROVENTION, INC WEB SL 17 SINGLE LAYER; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number W5-3-2

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 04/08/2024

Event Type  malfunction  

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 and therefore not available for return and investigation by the manufacturer.However, imaging was provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Event Description

It was reported: the physician chose a web 3x2 to treat a left media bifurcation aneurysm.The web was placed in the aneurysm and an attempt was made to detach it using the wdc2.However, the web did not detach even after several attempts.Physician was able to detach the web by strong manipulation of the microcatheter.Web remains implanted.It was noted the patient is doing well.

Event Description

No additional information was received, please see h6 & h11.

Manufacturer Narrative

Procedure/medical information review: imaging review - a 3.41 gb dicom file is submitted.It contains multiple dsas of the left ica, subtracted, unsubtracted, with and without contrast, as well as flat plate cts.It is dated (b)(6) 2024.The first set of images is at 14h57; the last set is at 16h43.The angiograms show a small left mca bifurcation aneurysm.From the beginning of the exam to 16h38, catheterization of the aneurysm with the microcatheter and placement of a non-detached small web are seen.At 16h39, the web is detached and subsequent runs show that the web is in satisfactory position; the vascular anatomy is otherwise normal, and there is no evidence of distal emboli.These images do not explain why it was difficult to detach the web.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.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.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.Ifu review (additional information can be found in the ifu): potential complications: potential complications include but are not limited to the following: hematoma at the site of entry, aneurysm rupture, emboli, vessel perforation, parent artery occlusion, hemorrhage, ischemia, vasospasm, clot formation, device migration or misplacement, premature or difficult device detachment, non-detachment, incomplete aneurysm filling, revascularization, post-embolization syndrome, and neurological deficits including stroke and death.Warnings and precautions: the web aneurysm embolization system is intended for single use only.The detachment control device is intended to be used for one patient.Do not resterilize and/or reuse the device.Reuse and/or resterilization can increase risk of infection, cause a pyrogenic response or other life threatening complications.Reuse and/or resterilization can degrade product performance, leading to device malfunction.Dispose of all devices in accordance with applicable hospital, administrative and/or local government policy.Advance and retract the device slowly.Do not advance the delivery device with excessive force.Determine the cause of any unusual resistance.Remove the device if excessive friction is noted and check for damage.Do not rotate the delivery device during or after delivery of the embolization device.Rotating the device may result in damage or premature detachment.The embolization device cannot be detached with any other power source other than a microvention inc.Detachment control device.Ensure that at least two detachment control devices are available before initiating an embolization procedure.Procedure detachment of the device: 31.The detachment control device is pre-loaded with batteries and will activate when the delivery device is properly connected.32.Verify that the rhv is firmly locked around the delivery device before attaching the detachment control device to ensure that the embolization device does not move during the connection process.33.Ensure that the delivery device gold connectors are clean and free from blood or contrast.If necessary, wipe the connectors with sterile water and dry before connecting.34.Insert the proximal end of the delivery device into the detachment control device.When the delivery device is properly connected, the light will flash green and an intermittent tone will be heard.35.Verify the embolization device position before pressing the detachment button.36.Push the detachment button.During firing, the light should be solid green and the beep should be continuous.37.Verify detachment by first loosening the rhv valve, then pulling back slowly on the delivery device and verifying that there is not embolization device movement.If the embolization device does not detach, push the detachment button again.If the device is still not detached, obtain a new detachment control device and attempt detachment up to two additional times.If it does not detach, remove the delivery device.38.Verify the position of the embolization device angiographically through the guide catheter.39.Prior to removing the microcatheter from the treatment site, place an appropriately sized guidewire completely through the microcatheter lumen to ensure that no part of the embolization device remains within the microcatheter.Investigation conclusion: a 3.41 gb dicom file was provided for review.It contains multiple dsas of the left ica, subtracted, unsubtracted, with and without contrast, as well as flat plate cts.It is dated (b)(6) 2024.The first set of images is at 14h57; the last set is at 16h43.The angiograms show a small left mca bifurcation aneurysm.From the beginning of the exam to 16h38, catheterization of the aneurysm with the microcatheter and placement of a non-detached small web are seen.At 16h39, the web is detached and subsequent runs show that the web is in satisfactory position; the vascular anatomy is otherwise normal, and there is no evidence of distal emboli.These images do not explain why it was difficult to detach the web.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.

• Brand Name: WEB SL 17 SINGLE LAYER
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19149649
• MDR Text Key: 341370180
• Report Number: 2032493-2024-00315
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00840273200109
• UDI-Public: (01)00840273200109(11)231019(17)280930(10)0000443909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-3-2
• Device Lot Number: 0000443909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1