MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number FG29040-020

Device Problem Migration (4003)

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

Event Date 05/28/2019

Event Type  Injury  

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 remains implanted in the patient; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies migration or misplacement as potential complications associated with use of the device.

Event Description

As reported through the article title, "successful webectomy during embolization of temporal arteriovenous malformation associated flow-related basilar aneurysms", endovascular treatment of two broad necked flow-related aneurysms was planned aided by web-sl (woven endobridge-single layer) devices in a patient with known left temporal arteriovenous malformation.Inadvertent distal migration occurred while performing a control angiogram with an automated iodine injector.Immediate retrieval was successfully performed using a solitaire stent-retriever.The patient presented with an incidentally discovered spetzler-martin grade-iii left temporal arteriovenous malformation (avm) that was supplied by multiple feeders from the left temporal branch of the middle cerebral artery (mca) and the left posterior cerebral artery (pca) and concomitant superficial venous drainage into the vein of labbe.Two flow-related aneurysms were evident on the 3d angiography at the distal basilar artery (ba) and left sca measuring 5.01 x 3.88mm and 3.61 x 4.2mm respectively.Given the aneurysm size, relatively regular geometry, incorporation of sca into the neck of the proximal aneurysm, and broad-neck morphology of the distal basilar artery (ba) aneurysm, the decision was made to embolize both aneurysms with intrasaccular web devices.The patient was pre-loaded with clopidogrel 75 mg/d for 5 days ahead of the procedure.Access to the aneurysm was obtained in a triaxial fashion under systemic anticoagulation while maintaining activated coagulation time (act) between 250-300 s.Through a 6f long femoral sheath, a 6fr sophia intermediate catheter was navigated over 0.035in guide wire till the mid-basilar artery.Several attempts to access the sca aneurysm via a pre-shaped angled 45, 90 degrees microcatheter over a 0.014in synchro microwire failed.Finally, a pre-shaped j microcatheter provided intra-aneurysmal stabilization permitting uneventful deployment of web sl 5-4 x 2 following appropriate size determination based on a simulation software.A second web sl 5-4 x 3 was delivered into the more distal aneurysm yet after resheathing for proper repositioning; the proximally implanted web (web sl 5-4 x 2) device went out of the aneurysmal sac instantly and migrated distally into the left pca.Retrograde image interpretation portrayed the web reconfiguration inside the aneurysmal sac just before the unfortunate dislocation, which might be attributed to the high-volume contrast injection mediated by the automated injector and further facilitated by the high placement of sophia intermediate catheter proximate to the aneurysmal orifice.Immediate navigation of a microcatheter over a microwire was performed till the p2 segment of the left pca by-passing the migrated device.Then a 4 x 20mm a stent-retriever was deployed successfully with light forward tension aiming at good wall apposition and tight engagement of the web device.Subsequently, the web grasped within the struts of the stent-retriever were gently retrieved as a one unit inside the sophia catheter with no technical complications.After webectomy, the control dsa revealed a patent posterior cerebral vasculature with no distal flow compromise.Thereafter, a second web sl 5-4 x 2 device was deployed successfully inside the sca aneurysm.On the interpretation of vasoct, the intrasaccular web device seems to be adequately opposed to the aneurysmal wall with no protrusion into the parent artery.Repeated attempts to deliver various sizes of the web sl 5-4 x 3, web sl 5-6 x 3 in the distal aneurysm without protrusion in the parent artery were futile.To avoid further thromboembolic consequences associated with lengthy procedural times, a repeat coil-assisted embolization session was conceived.The post-procedural recovery period was uneventful and the patient was discharged whilst being kept on mono antiplatelet therapy for 48 hours.

Event Description

As reported through the article title, "successful webectomy during embolization of temporal arteriovenous malformation associated flow-related basilar aneurysms", endovascular treatment of two broad necked flow-related aneurysms was planned aided by web-sl (woven endobridge-single layer) devices in a patient with known left temporal arteriovenous malformation.Inadvertent distal migration occurred while performing a control angiogram with an automated iodine injector.Immediate retrieval was successfully performed using a solitaire stent-retriever.The patient presented with an incidentally discovered spetzler-martin grade-iii left temporal arteriovenous malformation (avm) that was supplied by multiple feeders from the left temporal branch of the middle cerebral artery (mca) and the left posterior cerebral artery (pca) and concomitant superficial venous drainage into the vein of labbe.Two flow-related aneurysms were evident on the 3d angiography at the distal basilar artery (ba) and left sca measuring 5.01 x 3.88mm and 3.61 x 4.2mm respectively.Given the aneurysm size, relatively regular geometry, incorporation of sca into the neck of the proximal aneurysm, and broad-neck morphology of the distal basilar artery (ba) aneurysm, the decision was made to embolize both aneurysms with intrasaccular web devices.The patient was pre-loaded with clopidogrel 75 mg/d for 5 days ahead of the procedure.Access to the aneurysm was obtained in a triaxial fashion under systemic anticoagulation while maintaining activated coagulation time (act) between 250-300 s.Through a 6f long femoral sheath, a 6fr sophia intermediate catheter was navigated over 0.035in guide wire till the mid-basilar artery.Several attempts to access the sca aneurysm via a pre-shaped angled 45, 90 degrees microcatheter over a 0.014in synchro microwire failed.Finally, a pre-shaped j microcatheter provided intra-aneurysmal stabilization permitting uneventful deployment of web sl 5-4 x 2 following appropriate size determination based on a simulation software.A second web sl 5-4 x 3 was delivered into the more distal aneurysm yet after resheathing for proper repositioning; the proximally implanted web (web sl 5-4 x 2) device went out of the aneurysmal sac instantly and migrated distally into the left pca.Retrograde image interpretation portrayed the web reconfiguration inside the aneurysmal sac just before the unfortunate dislocation, which might be attributed to the high-volume contrast injection mediated by the automated injector and further facilitated by the high placement of sophia intermediate catheter proximate to the aneurysmal orifice.Immediate navigation of a microcatheter over a microwire was performed till the p2 segment of the left pca by-passing the migrated device.Then a 4 x 20mm a stent-retriever was deployed successfully with light forward tension aiming at good wall apposition and tight engagement of the web device.Subsequently, the web grasped within the struts of the stent-retriever were gently retrieved as a one unit inside the sophia catheter with no technical complications.After webectomy, the control dsa revealed a patent posterior cerebral vasculature with no distal flow compromise.Thereafter, a second web sl 5-4 x 2 device was deployed successfully inside the sca aneurysm.On the interpretation of vasoct, the intrasaccular web device seems to be adequately opposed to the aneurysmal wall with no protrusion into the parent artery.Repeated attempts to deliver various sizes of the web sl 5-4 x 3, web sl 5-6 x 3 in the distal aneurysm without protrusion in the parent artery were futile.To avoid further thromboembolic consequences associated with lengthy procedural times, a repeat coil-assisted embolization session was conceived.The post-procedural recovery period was uneventful and the patient was discharged whilst being kept on mono antiplatelet therapy for 48 hours.

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 remains implanted in the patient; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies migration or misplacement as potential complications associated with use of the device.

Manufacturer Narrative

Correction: d4 (model number).Additional information: b3, d4 (lot number), h4, h10.Additional information was received that provided event date and device lot number.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.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13014987
• MDR Text Key: 285240475
• Report Number: 2032493-2021-00498
• Device Sequence Number: 1
• Product Code: OPR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P170032
• 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,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: FG29040-020
• Device Lot Number: 18030803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2018
• 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
• Patient Age: 71 YR
• Patient Sex: Female