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

Catalog Number ENCR402300

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

Patient Problem Aneurysm (1708)

Event Date 12/30/2021

Event Type  Injury  

Event Description

As reported via the empower study, a (b)(6) female patient with no recorded medical history underwent stent-assisted coil embolization of an unruptured internal carotid artery (ica) on (b)(6) 2021 and experienced recurrence of right ica aneurysm at the neck on (b)(6) 2021.No action was taken.The event has not resolved.Per the principal investigator (pi), the event was mild in severity, possibly related to dual antiplatelet therapy and not likely related to the study device and study procedure.The saccular aneurysm had the following dimensions: maximum aneurysm diameter 3.81mm and neck width 3.18mm.The parent vessel diameter was 3.25mm.Stent-assisted coil embolization was successfully performed with the implantation of a 4mm x 23mm no tip enterprise¿ 2 vascular reconstruction device (encr402300 / 6000730) and unspecified coils.There were no reported intraoperative complications or study device deficiencies.Immediate post-procedure assessment showed raymond-roy score of class i: 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.Digital subtraction angiography (dsa) performed at the 180-day (6-month) follow-up visit on (b)(6) 2021 showed raymond-roy score of class ii: residual neck (contrast filling in aneurysm neck but none in aneurysm body).There was no evidence of hemorrhage/rupture or in-stent stenosis/thrombosis.Additional information was received from the study team on (b)(6) 2022.The site confirmed that the recurrence was of the target aneurysm that was treated with the study device.No intervention/treatment was performed.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient weight, race, and ethnicity were not provided.Initial reporter name and address: the name, phone and email address of the initial reporter are not available / reported.[conclusion]: as reported via the empower study, a (b)(6) female patient with no recorded medical history underwent stent-assisted coil embolization of an unruptured internal carotid artery (ica) on (b)(6) 2021 and experienced recurrence of right ica aneurysm at the neck on (b)(6) 2021.No action was taken.The event has not resolved.Per the principal investigator (pi), the event was mild in severity, possibly related to dual antiplatelet therapy and not likely related to the study device and study procedure.The saccular aneurysm had the following dimensions: maximum aneurysm diameter 3.81mm and neck width 3.18mm.The parent vessel diameter was 3.25mm.Stent-assisted coil embolization was successfully performed with the implantation of a 4mm x 23mm no tip enterprise¿ 2 vascular reconstruction device (encr402300 / 6000730) and unspecified coils.There were no reported intraoperative complications or study device deficiencies.Immediate post-procedure assessment showed raymond-roy score of class i: 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.Digital subtraction angiography (dsa) performed at the 180-day (6-month) follow-up visit on (b)(6) 2021 showed raymond-roy score of class ii: residual neck (contrast filling in aneurysm neck but none in aneurysm body).There was no evidence of hemorrhage/rupture or in-stent stenosis/thrombosis.Additional information was received from the study team on (b)(6) 2022.The site confirmed that the recurrence was of the target aneurysm that was treated with the study device.No intervention/treatment was performed.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 6000730.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.No determination of causes and possible contributing factors could be made.As a result, we are closing this investigation.Aneurysm recanalization is a condition requiring additional intervention or retreatment or can be reasonably expected to result in medical or surgical intervention, including hospitalization.Furthermore, the relationship of the study device to the reported aneurysm recanalization cannot be excluded.Thus, the event is considered serious and mdr reportable.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 08-jun-2022.[additional information]: modified information was received on 08-jun-2022.The information was reviewed.The adverse event term "recurrence of right internal carotid aneurysm at the neck¿ has been changed to "the right internal cervical aneurysm has recurred.¿ there is no new information that alters the previous file type determination, coding, and/or reportability determinations.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
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14164098
• MDR Text Key: 293462000
• Report Number: 3008114965-2022-00303
• 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
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Catalogue Number: ENCR402300
• Device Lot Number: 6000730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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): Life Threatening
• Patient Age: 53 YR
• Patient Sex: Female