MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX16MM; INTRACRANIAL NEUROVASCULAR STENT

Model Number ENF401612

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

Patient Problem Thromboembolism (2654)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Patient identifier: (b)(6).(b)(4).A supplemental report will be submitted if new facts arise, which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported via (b)(6) study, a (b)(6)-year old female (subject: (b)(6)) with a past medical history of hypertension (since 2010) underwent stent-assisted coil embolization of an anterior communicating artery aneurysm on (b)(6) 2020 and experienced severe subarachnoid hemorrhage (sah) on (b)(6) 2020.No medical/surgical action was taken, and the patient has not recovered.Per the principal investigator (pi), the event was life-threatening and was possibly related to the study device and procedure.The event was considered unrelated to dual antiplatelet therapy.Intra-procedure angiography/imaging examination revealed an unruptured anterior communicating artery aneurysm with the following dimensions: maximum aneurysm diameter 9.6mm and neck size 7.2mm.The parent vessel diameter was 3.5mm.Stent-assisted coil embolization was performed with the implantation of a 4mm x 16mm enterprise 2 (encr401612/11198929) vascular reconstruction device (vrd).The stent and unspecified coils were successfully placed in the aneurysm.Immediate post-procedure assessment showed raymond-roy score of class 1: complete obliteration (no contrast filling in aneurysm body or neck).There were no reported study device deficiencies; however, the case report form (crf) noted stent thrombosis on the angiography/imaging examination-intra-procedure form.There was no report of aneurysm rupture or perforation.Modified information received from the clinical database received on 20-nov-2020 was reviewed.Adverse event of sah relationship updated from relationship with study device: possibly related to unrelated, relationship with study procedure updated from possibly related to unrelated, and relationship with dual antiplatelet therapy updated from unrelated to unlikely related.Modified information received from the clinical database received on 20-nov-2020 was reviewed.Adverse event of sah outcome was updated from not recovered /not resolved to fatal.Additional information received from the clinical database on 20-nov-2020 added date of death to (b)(6) 2020.This event led to neurological death.Date of neurological death was on (b)(6) 2020.Additional information and translation received on 02-dec-2020 indicated that the patient had two aneurysms.The first aneurysm was treated successfully during the stent-assisted coil embolization procedure that took place on (b)(6) 2020.The subject was enrolled into the (b)(6) study due to the first aneurysm.The sah event occurred during the treatment of the second aneurysm that took place on (b)(6) 2020.The sequence of events that took place leading up to the thrombosis (which occurred on (b)(6) 2020) entailed the following: a 7 mm ¿ 30 cm competitor jasper coil was unwound early during the procedure.During the process of managing this coil, the stent thrombosis was found by angiography.As a result, an intravenous bolus injection of tirofiban and intra-arterial pulse bolus injection of tirofiban was administered.The stent thrombus was eliminated confirmed by re-angiography.Factors contributing to thrombosis were considered to be related to endothelial injury at the neck of the aneurysm during the process of coil unwinding.Per the assessment of the pi, the event of sah was not related to the study device.As per the pi, the cause of the sah was related to the rupture of the aneurysm sac wall due to intraoperative coil tamponade.The additional information received from the clinical site confirmed that the cause of sah was related to the rupture of the aneurysm sac wall due to intraoperative coiling.Details of the procedure and sah event were provided as follows: the patient was placed in a supine position on the digital subtraction angiography (dsa) examination table.The patients bilateral inguinal region was disinfected and toweled routinely.Under general anesthesia and administration of heparin, a 6f envoy catheter was introduced into the c1 end of left internal carotid artery under the right femoral artery sheath with 0.035 water film guidewire fluoroscopy, and 3d angiography was performed first.After the selection of the appropriate working delivery position, the microcatheter tip was introduced into to the ipsilateral distal end of m1 using a selectplus stent microcatheter with a 0.014 in-synchro microcatheter.The microcatheter tip was then introduced into the tumor sac by shaping the echelon -14 45 ¿ microcatheter tip with a microcatheter wire.According to the size of the artery, 8 mm ¿ 30 cm-axium 3d coil was selected to occlude the aneurysm and a 4.0 mm ¿ 16 mm enterprise-2 stent was introduced through a stent delivery catheter to half release across the neck of the aneurysm.The patient's heart rate increased during the occlusion.Contrast agent spillage was found in the aneurysm sac, indicating aneurysm rupture and hemorrhage.As a result, protamine was given to neutralize the heparin.Subsequently, a 6 mm ¿ 20 mm-axium, 5 mm ¿ 20 mm-axium, 4 mm ¿ 12 mm-axium were quickly filled through the embolization catheter followed by a.3 mm ¿ 6 mm-axium, 2 mm ¿ 8 mm-axium, 2 mm ¿ 4 mm-axium, 2 mm ¿ 4 mm-axium, etc.The aneurysm cavity was tightly packed.The angiographic aneurysm did not show any more contrast overflow, and the stent was released.Whole cerebral angiography in working position showed that the parent artery and distal branches were developing delay.Considering the increase of blood pressure after the hemorrhage, dehydration drugs such as mannitol and furosemide were given to lower intracranial pressure.During the procedure the patient experienced symptoms of increased heart rate and blood pressure, and bilateral mydriasis.A ct scan revealed a large amount of intracranial hemorrhage.Therefore, the patient remained in intubation status assisted by ventilator maintenance and transferred to neurologic icu for further treatment.The symptoms did not resolve and the patient remained in a deep coma.The patient was discharged from the hospital on (b)(6) 2020.The vital signs of the patient were not stable before discharge.The investigator informed the family members that the patient was in critical condition and that there might be a life-threatening risk at any time during the transferring process of discharge.The patient's family members still requested that the patient be discharged from the hospital despite the risk.The clinical site confirmed that the patient had expired on (b)(6) 2020, as a result of the progressive sah.The device remains implanted, therefore, no further investigation can be performed.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot#: 11198929 the history records indicate this product was final inspection tested at (b)(6), and was determined to be acceptable.Stent thrombosis/occlusion, hemorrhage, and death are known potential adverse events that may be associated with the use of the enterprise 2 vrd in the intracranial arteries and are listed in the instructions for use (ifu) as such.There is no medical evidence to suggest that the sah which led to death was related to the enterprise 2 vrd device.The pi also reported that the sah and death event were not related to the study device or procedure rather the cause of the sah was related to the rupture of the aneurysm sac wall due to intraoperative coil (competitor) tamponade.There is no indication of any device performance or manufacturing issues related to the event.Based on the pis assessment of the sah and death event, and lack of evidence linking the reported event to the study device and procedure, the sah and death event does not meet mdr reporting criteria.Since the thrombosis was noted within the enterprise device and/or on same side as device and cannot be unrelated, the thrombosis event meets mdr reporting criteria.The file will be re-reviewed if additional information is received at a later date.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

Event Description

As reported via (b)(6) study, a (b)(6)-year old female (subject (b)(6)) with a past medical history of hypertension (since 2010) underwent stent-assisted coil embolization of an anterior communicating artery aneurysm on (b)(6) 2020, and experienced severe subarachnoid hemorrhage (sah) on (b)(6) 2020.No medical/surgical action was taken, and the patient has not recovered.Per the principal investigator (pi), the event was life-threatening and was possibly related to the study device and procedure.The event was considered unrelated to dual antiplatelet therapy.Intra-procedure angiography/imaging examination revealed an unruptured anterior communicating artery aneurysm with the following dimensions: maximum aneurysm diameter 9.6mm and neck size 7.2mm.The parent vessel diameter was 3.5mm.Stent-assisted coil embolization was performed with the implantation of a 4mm x 16mm enterprise 2 (encr401612/11198929) vascular reconstruction device (vrd).The stent and unspecified coils were successfully placed in the aneurysm.Immediate post-procedure assessment showed raymond-roy score of class 1: complete obliteration (no contrast filling in aneurysm body or neck).There were no reported study device deficiencies; however, the case report form (crf) noted stent thrombosis on the angiography/imaging examination-intra-procedure form.There was no report of aneurysm rupture or perforation.Modified information received from the clinical database received on 20-nov-2020 was reviewed.Adverse event of sah relationship updated from relationship with study device: possibly related to unrelated, relationship with study procedure updated from possibly related to unrelated, and relationship with dual antiplatelet therapy updated from unrelated to unlikely related.Modified information received from the clinical database received on 20-nov-2020 was reviewed.Adverse event of sah outcome was updated from not recovered /not resolved to fatal.Additional information received from the clinical database on 20-nov-2020 added date of death to (b)(6) 2020.This event led to neurological death.Date of neurological death was on (b)(6) 2020.Additional information and translation received on 02-dec-2020 indicated that the patient had two aneurysms.The first aneurysm was treated successfully during the stent-assisted coil embolization procedure that took place on (b)(6) 2020.The subject was enrolled into the (b)(6) study due to the first aneurysm.The sah event occurred during the treatment of the second aneurysm that took place on (b)(6) 2020.The sequence of events that took place leading up to the thrombosis (which occurred on (b)(6) 2020) entailed the following: a 7 mm ¿ 30 cm competitor jasper coil was unwound early during the procedure.During the process of managing this coil, the stent thrombosis was found by angiography.As a result, an intravenous bolus injection of tirofiban and intra-arterial pulse bolus injection of tirofiban was administered.The stent thrombus was eliminated confirmed by re-angiography.Factors contributing to thrombosis were considered to be related to endothelial injury at the neck of the aneurysm during the process of coil unwinding.Per the assessment of the pi, the event of sah was not related to the study device.As per the pi, the cause of the sah was related to the rupture of the aneurysm sac wall due to intraoperative coil tamponade.The additional information received from the clinical site confirmed that the cause of sah was related to the rupture of the aneurysm sac wall due to intraoperative coiling.Details of the procedure, and sah event were provided as follows: the patient was placed in a supine position on the digital subtraction angiography (dsa) examination table.The patients bilateral inguinal region was disinfected and toweled routinely.Under general anesthesia and administration of heparin, a 6f envoy catheter was introduced into the c1 end of left internal carotid artery under the right femoral artery sheath with 0.035 water film guidewire fluoroscopy, and 3d angiography was performed first.After the selection of the appropriate working delivery position, the microcatheter tip was introduced into to the ipsilateral distal end of m1 using a selectplus stent microcatheter with a 0.014 in-synchro microcatheter.The microcatheter tip was then introduced into the tumor sac by shaping the echelon -14 45 ¿ microcatheter tip with a microcatheter wire.According to the size of the artery, 8 mm ¿ 30 cm-axium 3d coil was selected to occlude the aneurysm and a 4.0 mm ¿ 16 mm enterprise-2 stent was introduced through a stent delivery catheter to half release across the neck of the aneurysm.The patient's heart rate increased during the occlusion.Contrast agent spillage was found in the aneurysm sac, indicating aneurysm rupture and hemorrhage.As a result, protamine was given to neutralize the heparin.Subsequently, a 6 mm ¿ 20 mm-axium, 5 mm ¿ 20 mm-axium, 4 mm ¿ 12 mm-axium were quickly filled through the embolization catheter followed by a.3 mm ¿ 6 mm-axium, 2 mm ¿ 8 mm-axium, 2 mm ¿ 4 mm-axium, 2 mm ¿ 4 mm-axium, etc.The aneurysm cavity was tightly packed.The angiographic aneurysm did not show any more contrast overflow, and the stent was released.Whole cerebral angiography in working position showed that the parent artery and distal branches were developing delay.Considering the increase of blood pressure after the hemorrhage, dehydration drugs such as mannitol and furosemide were given to lower intracranial pressure.During the procedure the patient experienced symptoms of increased heart rate and blood pressure, and bilateral mydriasis.A ct scan revealed a large amount of intracranial hemorrhage.Therefore, the patient remained in intubation status assisted by ventilator maintenance and transferred to neurologic icu for further treatment.The symptoms did not resolve and the patient remained in a deep coma.The patient was discharged from the hospital on (b)(6) 2020.The vital signs of the patient were not stable before discharge.The investigator informed the family members that the patient was in critical condition, and that there might be a life-threatening risk at any time during the transferring process of discharge.The patient's family members still requested that the patient be discharged from the hospital despite the risk.The clinical site confirmed that the patient had expired on (b)(6) 2020 as a result of the progressive sah.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: modified information received on 01 jun 2021 was reviewed.Surgical treatment (i.E., ventricular drilling and drainage) was required for the subarachnoid hemorrhage event.The patient experienced severe brainstem failure, brain herniation, and central diabetes insipidus on 11 nov 2020.Medical intervention was provided; but the patient did not recover.The patient expired on 13 nov 2020.According to the pi, the events were not related to the study device or procedure and not likely related to dual antiplatelet therapy.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: modified information received on 18-aug-2021 was reviewed.Adverse event term ¿subarachnoid hemorrhage¿ was updated to ¿ruptured intracranial aneurysm with subspace arachnoid hemorrhage¿.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENTERPRISE2 4MMX16MM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 10967728
• MDR Text Key: 220646315
• Report Number: 1226348-2020-00478
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10886704075332
• UDI-Public: 10886704075332
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: ENF401612
• Device Catalogue Number: ENCR401612
• Device Lot Number: 11198929
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 06/01/2021; 08/18/2021
• Supplement Dates FDA Received: 06/21/2021; 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.014 IN-SYNCHRO MICROCATHETER; 2 MM × 4 MM-AXIUM COIL; 2 MM × 4 MM-AXIUM COIL; 2 MM × 8 MM-AXIUM COIL; 3 MM × 6 MM-AXIUM COIL; 4 MM × 12 MM-AXIUM COIL; 5 MM × 20 MM-AXIUM COIL; 6 MM × 20 MM-AXIUM COIL; 6F ENVOY CATHETER; 7 MM × 30 CM COMPETITOR JASPER COIL; 8 MM × 30 CM-AXIUM 3D COIL; ECHELON -14 45 ° MICROCATHETER TIP; SELECTPLUS STENT MICROCATHETER
• Patient Age: 53 YR