MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Model Number 400SMTXSFT0202

Device Problem Premature Separation (4045)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-01028.

Event Description

On (b)(6) 2020, the patient underwent a coil embolization procedure in the middle cerebral artery (mca) penumbra smart coils (smart coils), non-penumbra stent (atlas) and, non-penumbra microcatheters.During the procedure, after placing an atlas stent in the aneurysm using the microcatheter, the physician removed the microcatheter and advanced a new microcatheter into the target vessel.Next, while advancing a smart coil (2mm x 2cm) into the aneurysm, the microcatheter began to kick back during position of the last portion of the smart coil.Consequently, the smart coil unintentionally detached with most of the coil placed in the aneurysm and the tail end of the smart coil was protruding out of the aneurysm lumen and into the parent vessel within the stent.The physician therefore removed the microcatheter and re-advanced the same microcatheter that was previously used through the stent and placed inside of the aneurysm.The physician advanced another smart coil (1.5mm x 2cm) into the aneurysm; however, the physician experienced resistance while advancing the final portion of the smart coil and the microcatheter began to kick back.Therefore, the smart coil was retracted and the microcatheter was re-advanced over the smart coil back into the aneurysm.While re-advancing the same smart coil (1.5mm x 2cm), there was increase in blood pressure with suspicion of aneurysm perforation with subsequent deployment and detachment of the smart coil (1.5mm x 2cm) and another smart coil (1mm x 1cm) in the aneurysm.Concurrently, protamine was administered, and hyperventilation was initiated.Systolic blood pressure (sbp) was reported to be reduced below 110.A follow up angiography was performed confirming the suspected contrast extravasation from the aneurysm.The final smart coil (1mm x 1cm) was then deployed; however, while positioning the final portion of the smart coil, the physician noticed tail end of the first smart coil that was protruding out of the aneurysm had unraveled further distally into the right superior division of the m2branch.The physician successfully placed the final smart coil.An additional angiography was performed confirming stable coil loops with the protruding tail of the first smart coil and no further contrast extravasation.Filling defects on the protruding coil loop concerning for thrombus was noted; however, there was persistent flow distal to the stent of the superior right mca branch.A computed tomography (ct) scan revealed the right cerebral convexity subarachnoid hemorrhage and no midline shift was noted with hydrocephalus.Mannitol and hyperventilation were initiated with reversal of heparin with protamine.A neurosurgery team then performed an emergent external ventricular drain (evd) placement.An angiogram of the right internal carotid artery (ica) was performed approximately an hour apart resulted in the right mca in-stent stenosis and stable protruding coil loop.There was no distal embolic nor thromboembolic complications noted on final angiograms.Super selective intra-procedure internal carotid artery cerebral angiograms were obtained and demonstrated raymond- roy occlusion score i.There was no evidence of aneurysmal sac opacification.The tail of the smart coil was noted to be protruding into the parent artery with no hemodynamic delay.On (b)(6) 2020, the patient was discharged home with the modified rankin scale (mrs) 1; no significant disability despite symptoms and is able to carry out all usual duties and activities.The symptomatic intracranial hemorrhage was reported to be a serious adverse event with a probable relationship to the smart coils and a definite relationship to the index procedure.The aneurysm perforation was reported to be a serious adverse event with a probable relationship to the smart coils and a definite relationship to the index procedure.

Manufacturer Narrative

Please note that the following sections are being updated based on additional information provided by a penumbra clinical team on 08/07/2020: 1.Section b.Box 5.Describe event or problem.This report is associated with mfr report number: 3005168196-2020-01028.

Event Description

On (b)(6) 2020, the patient underwent a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils), non-penumbra stent and, non-penumbra microcatheters.During the procedure, after placing the stent in the aneurysm using the microcatheter, the physician removed the microcatheter and advanced a new microcatheter into the target vessel.Next, while advancing a smart coil (2mm x 2cm) into the aneurysm, the microcatheter began to kick back during position of the last portion of the smart coil.Consequently, the smart coil unintentionally detached with most of the coil placed in the aneurysm and the tail end of the smart coil was protruding out of the aneurysm lumen and into the parent vessel within the stent.The physician therefore removed the microcatheter and re-advanced the same microcatheter that was previously used through the stent and placed inside of the aneurysm.The physician advanced another smart coil (1.5mm x 2cm) into the aneurysm; however, the physician experienced resistance while advancing the final portion of the smart coil and the microcatheter began to kick back.Therefore, the microcatheter was re-advanced over the smart coil back into the aneurysm and the smart coil was removed.While advancing another smart coil (1.5mm x 2cm), it was noted that there was increase in blood pressure with suspicion of aneurysm perforation with subsequent deployment and detachment of the smart coil (1.5mm x 2cm) and another smart coil (1mm x 1cm) in the aneurysm.Concurrently, protamine was administered, and hyperventilation was initiated.Systolic blood pressure (sbp) was reported to be reduced below 110.A follow up angiography was performed confirming the suspected contrast extravasation from the aneurysm.The final smart coil (1mm x 1cm) was then deployed; however, while positioning the final portion of the smart coil, the physician noticed tail end of the first smart coil that was protruding out of the aneurysm had unraveled further distally into the right superior division of the m2 branch.The physician successfully placed the final smart coil.An additional angiography was performed confirming stable coil loops with the protruding tail of the first smart coil and no further contrast extravasation.Filling defects on the protruding coil loop concerning for thrombus was noted; however, there was persistent flow distal to the stent of the superior right mca branch.A computed tomography (ct) scan revealed the right cerebral convexity subarachnoid hemorrhage and no midline shift was noted with hydrocephalus.Mannitol and hyperventilation were initiated with reversal of heparin with protamine.A neurosurgery team then performed an emergent external ventricular drain (evd) placement.An angiogram of the right internal carotid artery (ica) was performed approximately an hour apart resulted in the right mca in-stent stenosis and stable protruding coil loop.There was no distal embolic nor thromboembolic complications noted on final angiograms.Super selective intra-procedure internal carotid artery cerebral angiograms were obtained and demonstrated raymond- roy occlusion score i.There was no evidence of aneurysmal sac opacification.The tail of the smart coil was noted to be protruding into the parent artery with no hemodynamic delay.On 04-jul-2020, the patient was discharged home with the modified rankin scale (mrs) 1; no significant disability despite symptoms and is able to carry out all usual duties and activities.The symptomatic intracranial hemorrhage was reported to be a serious adverse event with a probable relationship to the smart coils and a definite relationship to the index procedure.The aneurysm perforation was reported to be a serious adverse event with a probable relationship to the smart coils and a definite relationship to the index procedure.

Manufacturer Narrative

Results: the pet lock was separated approximately 0.4 cm from the proximal end of the pusher assembly.The pusher assembly was kinked at approximately 5.0, 144.0 and 148.0 cm from the proximal end.The pull wire was retracted out of the pusher assembly distal detachment tip (ddt) and the embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned smart coil pusher assembly revealed that the pet lock was separated on the proximal end of the pusher assembly.If the pet lock is separated the embolization coil will detach.Separation of the pet lock typically indicates an attempt to detach the embolization coil.If the pet lock is separately inadvertently, the embolization coil will become detached.The detached embolization coil was implanted and not returned for evaluation.Further evaluation revealed pusher assembly kinks.These kinks were likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Please note that the following sections is being updated based on additional information provided by a penumbra clinical team on (b)(6) 2020: section b.Box 5.Describe event or problem this report is associated with mfr report number: 3005168196-2020-01028.H3 other text: placeholder.

Event Description

On (b)(6) 2020, the patient underwent a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils), non-penumbra stent and, non-penumbra microcatheters.During the procedure, after placing an atlas stent in the aneurysm using the microcatheter, the physician removed the microcatheter and advanced a new microcatheter into the target vessel.Next, while advancing a smart coil (2mm x 2cm) into the aneurysm, the microcatheter began to kick back during position of the last portion of the smart coil.Consequently, the smart coil unintentionally detached with most of the coil placed in the aneurysm and the tail end of the smart coil was protruding out of the aneurysm lumen and into the parent vessel within the stent.The physician therefore removed the microcatheter and re-advanced the same microcatheter that was previously used through the stent and placed inside of the aneurysm.The physician advanced another smart coil (1.5mm x 2cm) into the aneurysm; however, the physician experienced resistance while advancing the final portion of the smart coil and the microcatheter began to kick back.Therefore, the microcatheter was re-advanced over the smart coil back into the aneurysm and the smart coil was removed.While advancing another smart coil (1.5mm x 2cm), it was noted that there was increase in blood pressure with suspicion of aneurysm perforation with subsequent deployment and detachment of the smart coil (1.5mm x 2cm) and another smart coil (1mm x 1cm) in the aneurysm.Concurrently, protamine was administered, and hyperventilation was initiated.Systolic blood pressure (sbp) was reported to be reduced below 110.A follow up angiography was performed confirming the suspected contrast extravasation from the aneurysm.The final smart coil (1mm x 1cm) was then deployed; however, while positioning the final portion of the smart coil, the physician noticed tail end of the first smart coil that was protruding out of the aneurysm had unraveled further distally into the right superior division of the m2 branch.The physician successfully placed the final smart coil.An additional angiography was performed confirming stable coil loops with the protruding tail of the first smart coil and no further contrast extravasation.Filling defects on the protruding coil loop concerning for thrombus was noted; however, there was persistent flow distal to the stent of the superior right mca branch.A computed tomography (ct) scan revealed the right cerebral convexity subarachnoid hemorrhage and no midline shift was noted with hydrocephalus.Mannitol and hyperventilation were initiated with reversal of heparin with protamine.A neurosurgery team then performed an emergent external ventricular drain (evd) placement.An angiogram of the right internal carotid artery (ica) was performed approximately an hour apart resulted in the right mca in-stent stenosis and stable protruding coil loop.There was no distal embolic nor thromboembolic complications noted on final angiograms.Super selective intra-procedure internal carotid artery cerebral angiograms were obtained and demonstrated raymond- roy occlusion score i.There was no evidence of aneurysmal sac opacification.The tail of the smart coil was noted to be protruding into the parent artery with no hemodynamic delay.On (b)(6) 2020, the patient was discharged home with the modified rankin scale (mrs) 1; no significant disability despite symptoms and is able to carry out all usual duties and activities.The symptomatic intracranial hemorrhage was reported to be a serious adverse event with a probable relationship to the smart coils and a definite relationship to the index procedure.The aneurysm perforation was reported to be a serious adverse event with a probable relationship to the smart coils and a definite relationship to the index procedure.On (b)(6) 2020, it was reported that the patient was experiencing right-sided neck and head pain with abnormal speech and generalized body tingling.A ct scan reveal mild frontal encephalomalacia from prior evc placement in the head and a ct angiography was performed of the head and neck that reveal no large vessel occlusion (lvo).On (b)(6) 2020, a magnetic resonance imaging (mri) of the brain revealed an acute lacunar infarct within the right middle corona radiata extending into the ipsilateral lentiform nucleus.No bleed or shift was identified.On the day of discharge, it was reported that the patient was experiencing resolution of headache with blurred vision.The patient was discharged home to continue with physical therapy (pt), occupational therapy (ot), and speech language therapy (st).Patient was alert and oriented with no acute complaints.The ischemic stroke was reported to be a serious adverse event with a possible relationship to the smart coils.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10324186
• MDR Text Key: 200423664
• Report Number: 3005168196-2020-01027
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015262
• UDI-Public: 00814548015262
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2020
• Device Model Number: 400SMTXSFT0202
• Device Catalogue Number: 400SMTXSFT0202
• Device Lot Number: F66457
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/25/2020
• Supplement Dates Manufacturer Received: 08/07/2020; 10/08/2020
• Supplement Dates FDA Received: 09/04/2020; 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR