MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

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

Patient Problems Visual Disturbances (2140); Urticaria (2278)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref.No: (b)(4).Information regarding patient weight, race, and ethnicity, were not provided.The initial reporter first name, phone and email address are not available / reported.[conclusion]: as reported via the (b)(6) study, a (b)(6) year-old female (subject (b)(6)) with no recorded medical history underwent stent-assisted coil embolization of an unruptured internal carotid artery (ica) aneurysm on (b)(6) 2021.The saccular aneurysm had the following dimensions: maximum aneurysm diameter 4.1mm and neck width 3.7mm.The parent vessel diameter was 4.0mm.Stent-assisted coil embolization was successfully performed with the implantation of a 4mm x 23mm enterprise 2 vascular reconstruction device (vrd) (encr402312 / 5964682) and unspecified coils.Immediate post-procedure assessment showed raymond-roy score of class 1: complete obliteration.Routine neurological examination performed prior to discharge on (b)(6) 2021 revealed hunt & hess grade 0 and modified rankin scale (mrs) score of 0.30-day follow-up visit was performed by phone on (b)(6) 2021.Digital subtraction angiography (dsa) examination is planned for the 180-day follow-up visit.It was reported that the patient experienced mild vertigo, tinnitus, and muscae volitantes (eye floaters) on the same day as the procedure.No action was taken, and the events have not resolved.Per the principal investigator (pi), the tinnitus event was not related to the study device, procedure, or dual antiplatelet therapy.The vertigo event was considered not likely related to the study device, procedure, or dual antiplatelet therapy.The muscae volitantes event was deemed possibly related to the study device and not related to the procedure or dual antiplatelet therapy.The events neither led to a disabling stroke nor in-stent thrombosis/stenosis.The patient developed a mild urinary tract infection (uti) on (b)(6) 2021.The uti was treated with oral antibiotics and the patient recovered on (b)(6) 2021.According to the pi, the event was not related to the study device, procedure, or dual antiplatelet therapy.The patient then experienced mild urticaria (hives) on (b)(6) 2021.Oral and intramuscular (im) medications were administered, and the event resolved on (b)(6) 2021.The pi felt that the event was possibly related to the study device, procedure, and dual antiplatelet therapy.None of these events were considered serious.On 16 june 2021, additional information was received indicated that the patient had a history of anaphylactic penicillin allergy at baseline.The patient was neither evaluated by an allergist nor was any allergy testing performed.Therefore, it is not known if the patient had any metal allergies at baseline.There were no intraoperative adverse events or study device deficiencies.Competitor coils were implanted during the procedure.There was no evidence of coil protrusion into the parent vessel.The patient reported floaters in the right eye immediately after the procedure.The patient was not examined by an ophthalmologist.The eye floaters were not associated with a stroke or thrombotic event and there was no limitation of activities of daily living (adls).No action was taken, and the event is ongoing.The investigator was unable to determine the exact cause of the event as this event is multi-factorial.The acute urticaria improved after four days of medical treatment.The patient was not hospitalized due to the event.There were no residual symptoms.The pi feels that there is no relationship of the reported urticaria to the study device.No further information was provided.Based on complaint information, the device remains implanted and is thus not available for evaluation.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 5964682.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Neurological deficits, such as visual field defects, and allergic reactions, including, but not limited to, contrast, nitinol metal, and medications, are known potential adverse events that may be associated with the use of the enterprise 2 vrd in the intracranial arteries.The enterprise 2 instructions for use (ifu) warns that persons with allergic reactions to nickel titanium (nitinol) may suffer an allergic response to this implant.No allergy testing was performed to evaluate whether the patient had any metal allergies.With the information provided, it is not possible to determine the root cause of the reported hives.However, there are patient, procedural, and pharmacological factors that may have contributed rather than the design or manufacture of the device.Furthermore, the pi reported that the hives were not related to the study device.Assignment of root cause for the reported muscae volitantes remains speculative and inconclusive.However, there are clinical and procedural factors that may have contributed.There was no information provided to indicate a device malfunction or reason for considering the muscae volitantes to be potentially related to the device.Since the muscae volitantes cannot be unrelated and has not resolved (i.E., permanent injury / impairment), the event meets mdr reporting criteria with an awareness date of 16 june 2021.The urticaria event was not considered related to the study device; therefore, the event does not meet mdr reporting criteria.There is no medical evidence to suggest that the reported events of vertigo, tinnitus, and uti were related to the enterprise 2 stent implanted in the cerebral vasculature.Common causes of vertigo include inner ear infections, migraines, and even some medications, including those used to treat high blood pressure or anxiety.In many people, tinnitus is caused by one of the following: hearing loss, ear infection or ear canal blockage, head or neck injuries, and medications.Utis typically occur when bacteria enter the urinary tract through the urethra and begin to multiply in the bladder.Utis are common in women, and many women experience more than one infection during their lifetimes.Risk factors specific to women for utis include female anatomy, sexual activity, and menopause.Other risk factors for utis include urinary tract abnormalities, blockages in the urinary tract, catheter use, a suppressed immune system, and/or a recent urinary procedure.Review of the available information suggests that patient and pharmacological factors may have contributed to the reported events.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

As reported via the (b)(6) study, a (b)(6) year-old female (subject (b)(6)) with no recorded medical history underwent stent-assisted coil embolization of an unruptured internal carotid artery (ica) aneurysm on (b)(6) 2021.The saccular aneurysm had the following dimensions: maximum aneurysm diameter 4.1mm and neck width 3.7mm.The parent vessel diameter was 4.0mm.Stent-assisted coil embolization was successfully performed with the implantation of a 4mm x 23mm enterprise 2 vascular reconstruction device (vrd) (encr402312 / 5964682) and unspecified coils.Immediate post-procedure assessment showed raymond-roy score of class 1: complete obliteration.Routine neurological examination performed prior to discharge on (b)(6) 2021 revealed hunt & hess grade 0 and modified rankin scale (mrs) score of 0.30-day follow-up visit was performed by phone on (b)(6) 2021.Digital subtraction angiography (dsa) examination is planned for the 180-day follow-up visit.It was reported that the patient experienced mild vertigo, tinnitus, and muscae volitantes (eye floaters) on the same day as the procedure.No action was taken, and the events have not resolved.Per the principal investigator (pi), the tinnitus event was not related to the study device, procedure, or dual antiplatelet therapy.The vertigo event was considered not likely related to the study device, procedure, or dual antiplatelet therapy.The muscae volitantes event was deemed possibly related to the study device and not related to the procedure or dual antiplatelet therapy.The events neither led to a disabling stroke nor in-stent thrombosis/stenosis.The patient developed a mild urinary tract infection (uti) on (b)(6) 2021.The uti was treated with oral antibiotics and the patient recovered on (b)(6) 2021.According to the pi, the event was not related to the study device, procedure, or dual antiplatelet therapy.The patient then experienced mild urticaria (hives) on (b)(6) 2021.Oral and intramuscular (im) medications were administered, and the event resolved on (b)(6) 2021.The pi felt that the event was possibly related to the study device, procedure, and dual antiplatelet therapy.None of these events were considered serious.On 16 june 2021, additional information was received indicated that the patient had a history of anaphylactic penicillin allergy at baseline.The patient was neither evaluated by an allergist nor was any allergy testing performed.Therefore, it is not known if the patient had any metal allergies at baseline.There were no intraoperative adverse events or study device deficiencies.Competitor coils were implanted during the procedure.There was no evidence of coil protrusion into the parent vessel.The patient reported floaters in the right eye immediately after the procedure.The patient was not examined by an ophthalmologist.The eye floaters were not associated with a stroke or thrombotic event and there was no limitation of activities of daily living (adls).No action was taken, and the event is ongoing.The investigator was unable to determine the exact cause of the event as this event is multi-factorial.The acute urticaria improved after four days of medical treatment.The patient was not hospitalized due to the event.There were no residual symptoms.The pi feels that there is no relationship of the reported urticaria to the study device.No further information was provided.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 01 july 2021.[additional information]: on 01 july 2021, additional information was received indicated that the patient had no relevant medical history/allergies at baseline except for penicillin anaphylaxis.There were no intraoperative adverse events or study device deficiencies.The muscae volitantes was confirmed during the 30-day follow-up visit performed via phone on (b)(6) 2021.The hives were systemic.Non-cerenovus coils were implanted during the procedure (eve 3d).The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 16-nov-2021.[additional information]: on (b)(6) 2021, modified information was received.The muscae volitantes event ¿relationship with study device¿ was changed from 'possibly related' to 'unrelated.' upon further review, the muscae volitantes no longer meets mdr reporting criteria medical device reporting since the event is unrelated to the study device.Therefore, it has been deemed not reportable.No further reports will be forthcoming.

• Brand Name: ENTERPRISE2 4MMX23MM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12017725
• MDR Text Key: 256774606
• Report Number: 1226348-2021-00037
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Catalogue Number: ENCR402312
• Device Lot Number: 5964682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• 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): Disability
• Patient Age: 36 YR
• Patient Sex: Female