MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC402300

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

Patient Problems Aneurysm (1708); Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that a patient with a medical history or severe atopy underwent an emergent endovascular treatment of a subarachnoid hemorrhage (sah) secondary to a ruptured vertebral artery aneurysm with a 4mm x 23mm enterprise 2 (enc402300 / 11175276) vascular reconstruction device (vrd) and competitor coil (s) and exhibited signs and symptoms of an allergic reaction after the procedure.The timing of allergic signs and symptoms onset in relation to the procedure on (b)(6) 2021 was not reported.Magnetic resonance imaging (mri) revealed ¿white part¿ around the stent.It was stated that there was a possibility of brain swelling.The patient received steroid medication as treatment and the symptoms have been stable.The physician commented that the patient may have had a metal allergy.It was further reported that the aneurysm is reopening, and additional intervention is planned at a later date.The enterprise 2 stent was reportedly utilized as per the instructions for use (ifu).The device remains implanted in the patient and is thus not available for evaluation.Based on complaint information, the device remains implanted and is thus not available for evaluation.(b)(6) region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 11175276.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.Allergic reaction to nitinol metal, cerebral edema, and aneurysm recanalization are known adverse events that may be associated with the use of the enterprise 2 stent and are listed in the instructions for use (ifu) as such.The ifu warns the user that persons with allergic reactions to nickel titanium (nitinol) may suffer an allergic response to this implant.It was reported that the patient may have a metal allergy, but it was not mentioned whether testing was performed to confirm the allergy.With the information provided, it is not possible to determine the root cause of the event.However, there are patient factors that may have contributed with no indication of a device defect or quality issue.Review of the available information does not allow for an exact determination of root cause for the aneurysm recanalization; however, factors which may have a correlation with recanalization following endovascular embolization include neck size, packing density, and inflow angle.Since the procedure was conducted during an emergent situation due to sah, coils may not have been placed as densely as needed.Root cause determination is pending additional investigation.Since the allergic reaction appears to have led to brain swelling (i.E., cerebral edema) and the relationship of the device to the reported event cannot be excluded, the event meets mdr reporting criteria with the classification of ¿serious injury.¿ the aneurysm recanalization meets mdr reporting criteria because of the need for additional surgical intervention.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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

The healthcare professional reported that a patient with a medical history or severe atopy underwent an emergent endovascular treatment of a subarachnoid hemorrhage (sah) secondary to a ruptured vertebral artery aneurysm with a 4mm x 23mm enterprise 2 (enc402300 / 11175276) vascular reconstruction device (vrd) and competitor coil (s) and exhibited signs and symptoms of an allergic reaction after the procedure.The timing of allergic signs and symptoms onset in relation to the procedure on (b)(6) 2021 was not reported.Magnetic resonance imaging (mri) revealed ¿white part¿ around the stent.It was stated that there was a possibility of brain swelling.The patient received steroid medication as treatment and the symptoms have been stable.The physician commented that the patient may have had a metal allergy.It was further reported that the aneurysm is reopening, and additional intervention is planned at a later date.The enterprise 2 stent was reportedly utilized as per the instructions for use (ifu).The device remains implanted in the patient and is thus not available for evaluation.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 12 july 2021.E.1: the initial reporter phone: (b)(6).[additional information]: on 12 july 2021, additional information was received.The information indicated that a certified translated copy of the mri report is not available.The mri revealed that there was brain swelling that the physician attributed to a metal allergy.The physician commented that the white part round the stent is likely due to brain swelling.The patient¿s symptoms were alleviated with steroid treatment.The patient also had competitor coils implanted.It was confirmed that the intended procedure was a stent-assisted coil embolization of the subarachnoid hemorrhage secondary to the ruptured vertebral artery aneurysm.Additional treatment will be provided at a later date for the recanalized aneurysm; however, the date has not been determined.Allergic reaction to nitinol metal, cerebral edema, and aneurysm recanalization are known adverse events that may be associated with the use of the enterprise 2 stent and are listed in the instructions for use (ifu) as such.The ifu warns the user that persons with allergic reactions to nickel titanium (nitinol) may suffer an allergic response to this implant.It was reported that the patient may have a metal allergy, but it was not mentioned whether testing was performed to confirm the allergy.With the information provided, it is not possible to determine the root cause of the event.However, there are patient factors that may have contributed with no indication of a device defect or quality issue.Review of the available information does not allow for an exact determination of root cause for the aneurysm recanalization; however, factors which may have a correlation with recanalization following endovascular embolization include neck size, packing density, and inflow angle.Since the procedure was conducted during an emergent situation due to sah, coils may not have been placed as densely as needed.Since the allergic reaction appears to have led to brain swelling (i.E., cerebral edema) and the relationship of the device to the reported event cannot be excluded, the event meets mdr reporting criteria with the classification of ¿serious injury.¿ the aneurysm recanalization meets mdr reporting criteria because of the need for additional surgical intervention.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.

• Brand Name: ENTERPRISE2 4MMX23MM NO TIP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 12050592
• MDR Text Key: 257778264
• Report Number: 3008114965-2021-00241
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Catalogue Number: ENC402300
• Device Lot Number: 11175276
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention