MAUDE Adverse Event Report: PULSERIDER Y 3MM, 8MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Model Number 301-D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Death (1802); Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893); Rupture (2208)

Event Date 12/05/2017

Event Type  Death  

Manufacturer Narrative

Product complaint #
=
> (b)(4).Patient information was not available.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during a pulserider (301d/ w262306) assisted coil embolization procedure of a recanalized basilar tip aneurysm (previous coils unknown), the aneurysm was ruptured by the tines of the pulserider.It was reported that the vessel was moderately tortuous and the aneurysm was not ruptured prior to the procedure.The pulserider was repositioned twice to get it in the left pca and inside the aneurysm on the right side-the takeoff of the pca¿s was a little difficult.The aneurysm was coiled with non-codman coils.The patient was stable the entire time and there was no change in the patient¿s vitals.The rupture was only discovered when doing a run after the procedure.Additional coils were implanted with balloon assistance, and the bleeding subsided.The patient was doing fine; however, an external ventricular drain (evd) was placed to relieve pressure that was placed due to the rupture.The device was not available for analysis.

Manufacturer Narrative

(b)(4).Additional information was received via a death summary report that was received on 12 jan 2018, but was inadvertently not included in the final mdr: on (b)(6) 2017, the patient underwent elective stent assisted coiling of recurrent basilar aneurysm with intra¬ procedure rupture.The patient was noted to have a left non-responsive pupil and right sluggish pupil, dyna ct revealed subarachnoid hemorrhage (sah), and an external ventricular drain (evd) was placed emergently.The patient improved initially to sluggish pupils.When they arrived in the neurosurgical intensive care unit, the patient was unresponsive, with non-reactive pupils and no motor function.An emergent head ct without contrast showing diffuse sah and contrast.Neurological exam slightly improved.On (b)(6) 2017, neurological exam remained stable.On (b)(6) 2017, neurological exam remained stable with sbp goal less than 140 and evd was at 10, with stable intracranial pressures (icps).The patient was tolerating tube feedings.Neurological exam declined on (b)(6) 2017 with evd not draining.The was an attempt to flush the evd with no improvement.The evd was repositioned by neurosurgery.Head ct was obtained with stable vents.The patient received two doses of hypertonic and was started on propofol overnight for intracranial hypertension.Neurological exam remained poor on (b)(6) 2017.Mri revealed thalamic, cerebellar and pons infarcts, as well as tract hemorrhage and blood throughout the midbrain, pons, and hippocampus.On (b)(6) 2017, transcranial dopplers showed mild vasospasm in the right and left middle cerebral arteries.Sbp goal was increased to less than 180.On (b)(6) 2017, neurological exam remained poor.The patient was febrile; however, fever work-up was negative.Intermittent icp spikes were responsive to osmotherapy and evd was draining at 5.On (b)(6) 2017, the patient had elevated icp and was unresponsive to verbal or tactile stimuli.The patient was pronouncement dead on (b)(6) 2017.The immediate cause of death was listed as cardiopulmonary arrest, hydrocephalus, subarachnoid hemorrhage and basilar artery aneurysm.Updated conclusion: aneurysm perforation or rupture, infarction, increased intracranial pressure and death are known procedural complication associated with the pulserider and is listed in the instructions for use (ifu) as such.The pulserider device is an intravascular device used to cover the neck of wide neck aneurysms located in arterial bifurcation points.The use of this device allows the introduction of coils to occlude the sac of the aneurysm preventing the coil protrusion into the parent vessel.The angiographic images were reviewed and demonstrated that during the procedure, the aneurysm was ruptured as indicated by the presence of contrasts outside the arterial system.This event occurred relatively early during the case.There was no clear documentation in the images provided that indicated the location of the aneurysm rupture.The strategy to address this intraprocedural complication was to complete the occlusion of the aneurysm by introducing coils in the patent aspect of the aneurysm and to reverse the heparinization.There was no indication of any device malfunction, neither in the operative report nor in the angiographic images available for review.This was the physician's first procedure using the pulserider device.The cause of the aneurysm rupture leading to extensive subarachnoid hemorrhage and intracranial hypertension and eventual death could be attributed to procedural maneuvers, which include the manipulations required to deploy the pulse rider device or the subsequent microcatheter and microwire maneuvers performed during the procedure.The ifu states that the pulserider anchor base is available to treat parent arteries from 2.7 mm to 4.5 mm and the patient had a parent vessel of 1.83 mm.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

Manufacturer Narrative

Product complaint # (b)(4).Additional information was received via medical records on 1/11/2018: the patient had been heparinized with 5000 units of heparin for the procedure.After pulserider deployment, but not detachment, the pulserider tines were present within the mid-basilar artery extending into the right lateral base of the aneurysm and left proximal p1 segment.The initial coil was well seated within the aneurysm recurrence sac.There was a small amount of contrast extravasation along the superior-lateral and posterior inferior aspect of the coil mass.Rapid stent assisted coil embolization was then initiated under roadmap guidance and control angiography of the aneurysm was performed by advancing a 3mm x 10cm hydrocoil into the aneurysm.The pulserider control angiography demonstrated the coil to be well seated in the aneurysm sac and the patient vessel was widely patent.The patient was given 20mg of intravenous protamine for heparin reversal.Further coil embolization of the aneurysm was then performed.Control angiography demonstrated the coils to be well seated in the recurrent aneurysm sac and the parent vessel to be widely patent.There was persistent small amount of contrast extravasation noted along the superior-lateral and posterior inferior aspect of the coil mass.Using roadmap guidance, a 4mm x 10mm balloon catheter was advanced into the proximal basilar artery and was gently insufflated for 5 minutes.Control angiography again demonstrated a persistent small amount of contrast extravasation along the superior-lateral and posterior inferior aspect of the coil mass.A balloon was again insufflated for 5 minutes; however, persistent small amount of contrast extravasation was demonstrated.Another coil was deployed with continued small contrast extravasation, now primarily at the left p1 basilar junction.A decision was made to sacrifice the proximal left p1 segment as the patient had large bilateral posterior communicating arteries.Five coils were deployed into the left p1 segment with no further evidence of contrast extravasation.Dyna ct post procedure demonstrated moderate diffuse subarachnoid hemorrhage primarily located within the basilar cisterns and along the sylvian fissures, as well as moderate intraventricular hemorrhage.There was no mass effect or loss of gray-white matter differentiation.The pulserider product was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Product complaint # (b)(4).Procedural images received on 2/9/2018 and were reviewed by medical safety officer (see below in conclusion).Conclusion: as reported by a healthcare professional, during a pulserider (301d/ w2623-06) assisted coil embolization procedure of a recanalized basilar tip aneurysm (previous coils unknown), the aneurysm was ruptured by the tines of the pulserider.Additional coils were implanted with balloon assistance, and the bleeding subsided.The patient had been heparinized with 5000 units of heparin for the procedure.After pulserider deployment, but not detachment, the pulserider tines were present within the mid-basilar artery extending into the right lateral base of the aneurysm and left proximal p1 segment.The initial coil was well seated within the aneurysm recurrence sac.There was a small amount of contrast extravasation along the superior-lateral and posterior inferior aspect of the coil mass.Rapid stent assisted coil embolization was then initiated under roadmap guidance and control angiography of the aneurysm was performed by advancing a 3mm x 10cm hydrocoil into the aneurysm.The pulserider control angiography demonstrated the coil to be well seated in the aneurysm sac and the patient vessel was widely patent.The patient was given 20mg of intravenous protamine for heparin reversal.Further coil embolization of the aneurysm was then performed.Control angiography demonstrated the coils to be well seated in the recurrent aneurysm sac and the parent vessel to be widely patent.There was persistent small amount of contrast extravasation noted along the superior-lateral and posterior inferior aspect of the coil mass.Using roadmap guidance, a 4mm x 10mm balloon catheter was advanced into the proximal basilar artery and was gently insufflated for 5 minutes.Control angiography again demonstrated a persistent small amount of contrast extravasation along the superior-lateral and posterior inferior aspect of the coil mass.A balloon was again insufflated for 5 minutes; however, persistent small amount of contrast extravasation was demonstrated.Another coil was deployed with continued small contrast extravasation, now primarily at the left p1 basilar junction.A decision was made to sacrifice the proximal left p1 segment as the patient had large bilateral posterior communicating arteries.Five coils were deployed into the left p1 segment with no further evidence of contrast extravasation.Dyna ct post procedure demonstrated moderate diffuse subarachnoid hemorrhage primarily located within the basilar cisterns and along the sylvian fissures, as well as moderate intraventricular hemorrhage.There was no mass effect or loss of gray-white matter differentiation.The patient was doing fine; however, an external ventricular drain (evd) was placed to relieve pressure that was placed due to the rupture.The pulserider device was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Procedural images were reviewed: the patient presented with an unruptured basilar artery tip aneurysm coiled which recanalized.During the cerebral angiogram, the left vertebral artery was selected and biplane dsa runs were obtained.The angiographic images demonstrated a large basilar tip aneurysm which was previously coiled and it has recanalized (re-opened).The coil mass's compaction has resulted in recanalization of the lower aspect of the aneurysm neck at the level of the basilar tip mostly leaving uncovered the left side of the aneurysm neck.The basilar artery tip presents a symmetric regression pattern.The two posterior cerebral arteries and superior cerebral arteries were opacified during the contrast injection.The upper third of the basilar artery diameter was 1.83 mm.The aneurysm's neck measures 5.07 mm and recanalized portion of the aneurysm measures in the longitudinal diameter is 4.52 mm.The pulsarrider device appeared positioned in the upper basilar artery and deployed with the two leaflets markers covering the neck of the aneurysm in the series 12 of the angiogram.(time: 12:19 pm) in the series 14, the microcatheter is placed into the aneurysm and some coils have been already introduced and deployed.(time:12:49 pm).There is a subtle radiopacity abutting the right side of the aneurysm sac suggesting rupture.In the series 17, it is already clearly demonstrating the progressive contrast extravasated and accumulated in the cisterns around of the aneurysm particularly noticeable in the right and posterior to the aneurysm.No clear demonstration of the aneurysm ruptured point.(time:1:02 pm) the coiling was concluded at 2:22 pm, with a complete occlusion of the aneurysm and it is also noted decreased contrast filling of the right posterior cerebral artery.At the end of case, a dyna ct-scan was obtained with the angiographic equipment and these tomographic images demonstrated extensive subarachnoid hemorrhage both in the posterior fossa and supratentorial compartment.It is also noted intraventricular blood.Diffuse brain edema and the tonsils herniation through the foramen magnum are also demonstrated.The operative report indicates that the heparinization was reversed using protamine.Aneurysm perforation or rupture is a known procedural complication associated with the pulserider and is listed in the instructions for use as such.The pulserider device is an intravascular device used to cover the neck of wide neck aneurysms located in arterial bifurcation points.The use of these device allows introduction of coils to occlude the sac of the aneurysm preventing the coil protrusion into the parent vessel.The angiographic images demonstrated that during the procedure the aneurysm was ruptured as indicated by the presence of contrasts outside the arterial system.This event occurred relatively early during the case.There was no clear documentation in the images provided indicating the location of the aneurysm rupture.The strategy to address this intraprocedural complication was to complete the occlusion of the aneurysm by introducing coils in the patent aspect of the aneurysm and to reverse the heparinization.There is no indication of any device malfunction neither in the operative report nor in the angiographic images available for review.The cause of aneurysm rupture leading to extensive subarachnoid hemorrhage and intracranial hypertension could be attributed to procedural maneuvers, which include the manipulations required to deploy the pulse rider device or the subsequent microcatheter and microwire maneuvers performed during the procedure.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: PULSERIDER Y 3MM, 8MM ARCH
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• MDR Report Key: 7150256
• MDR Text Key: 95894608
• Report Number: 3008680601-2017-00506
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005116
• UDI-Public: (01)00859030005116(17)190728(10)W2623-06
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 301-D
• Device Catalogue Number: 301D
• Device Lot Number: W2623-06
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention