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

Catalog Number ENCR402300

Device Problem Migration (4003)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 11/13/2023

Event Type  Injury  

Event Description

The healthcare professional reported that during an endovascular embolization procedure, a 4mm x 23mm no tip enterprise¿ 2 vascular reconstruction device (encr402300 / 8470639) was partially released.After about 1/3 of the coil, a 3mm x 6cm orbit galaxy mini complex fill (640cf0306 / 31047856) filled in the aneurysm, the coil was found to be separated into two pieces, while the rest of the coil was moved to the distal end of the parent vessel.The physician used a guidewire (unspecified brand) to capture the coil.It was found that the stent position had migrated.The two separated pieces of the coil, the stent and the 150cm x 5cm prowler select plus microcatheter (606s255x / 31085109) were wrapped together.The physician used an intermediate catheter (unspecified brand) to remove the coil, the stent, and the microcatheter from the patient and switched to competitor devices to complete the procedure.After the procedure, it was reported that the patient suffered from a middle cerebral artery bleed.Surgical drilling and drainage was initially performed and then transferred to a craniotomy due to excessive bleeding.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8470639.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.Stent migration is the movement of the stent away from the implant site after it has been deployed, which could lead to embolization, possibly ischemia or infarct.In this case, the series of events led to a cerebral hemorrhage, which required several additional surgical interventions to preclude patient harm/death.Based on this information, this event meets us fda reporting criteria under 21 cfr 803 with the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00893, and 3008114965-2023-00895.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 20-dec-2023.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00893, and 3008114965-2023-00895.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 submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 4mm x 23mm no tip enterprise¿ 2 vascular reconstruction device was received contained in the decontamination pouch.Visual inspection was performed.It was noted that only the detached stent component was returned for evaluation.The delivery wire and the introducer were not returned for evaluation.The stent component underwent microscopic inspection.It was observed to be in good condition; there was no structural damage (i.E., no broken struts, no kinks); also, it was noted fully expanded, both ends can be noted as completely flared.The issue documented in the complaint that the stent position had migrated cannot be replicated in the laboratory since the reported issue is specific to the patient and procedure at the time of occurrence.However, stent migration is a known potential issue associated with the use of the device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.With the limited information available, a conclusive cause cannot be determined; however, it is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.At this time, there is no evidence to support that the issue reported in the complaint is a result of a defect inherently related to the device.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8470639.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendation: ¿ select a stent length that is at least 10 mm longer than the aneurysm neck to maintain a minimum of 5 mm on either side of the aneurysm neck.A large differential in diameter between the proximal and distal segments of the parent vessel may increase the risk of stent migration.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00893, 3008114965-2023-00894, and 3008114965-2023-00895.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): CERENOVUS, INC.; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18241585
• MDR Text Key: 329434118
• Report Number: 3008114965-2023-00894
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2023

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 Catalogue Number: ENCR402300
• Device Lot Number: 8470639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/20/2023; 12/22/2023
• Supplement Dates FDA Received: 12/20/2023; 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2023
• 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
• Treatment: OG CMPLX FILL COIL 3X6; PROWLER SELECT PLUS 150/5CM
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female