MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR403012

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(6).Section h3 - 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.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.

Event Description

As reported by the field, during an endovascular embolization to the end of the right internal carotid artery, when an enterprise2 4mmx30mm intracranial stent (encr403012, 8269501) passed through the tip of a unspecified microcatheter (mc), the physician started to release it.The markers at the distal end of the stent were not visualized.Attempts were made to adjust the release of the stent, distal markers still could not be observed.The physician retracted and removed the stent from the patient and switched to a new stent to complete the surgery.The microcatheter was not replaced.Additional event information received on 03-apr-2024 indicated that the radiopaque was less than expected.There were no procedural delays due to the event.

Manufacturer Narrative

Product complaint #(b)(4).Complaint conclusion: as reported by the field, during an endovascular embolization to the end of the right internal carotid artery, when an enterprise2 4mmx30mm intracranial stent (encr403012, 8269501) passed through the tip of a unspecified microcatheter (mc), the physician started to release it.The markers at the distal end of the stent were not visualized.Attempts were made to adjust the release of the stent, distal markers still could not be observed.The physician retracted and removed the stent from the patient and switched to a new stent to complete the surgery.The microcatheter was not replaced.Additional event information received on 03-apr-2024 indicated that the radiopaque was less than expected.There were no procedural delays due to the event.A non-sterile 4mm x 30mm enterprise 2 vascular reconstruction device was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the stent was already detached from the unit.The delivery wire and the introducer were in good condition (i.E., no kinks, bents, or elongations).A microscopic examination was performed, and, under magnification, the 8 stent markers were confirmed to be properly assembled and undamaged.The stent was inspected under x-ray, and the markers were properly identified and visualized.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8269501.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The issue reported was not confirmed since the markers were properly identified and visualized during the evaluation.100% receiving inspection was completed on the marker band wire.The vrd stents require a distal and proximal marker wire made of tantalum.Tantalum is a radiopaque material.The detached condition of the stent was not originally reported; the exact time of occurrence cannot be determined, therefore, this issue is not related to the issue reported.During the manufacturing process each device undergoes 100% inspection for the following, which look for missing stent marker: verification of marker gluing.Verification of stent post-coating.There is a separate 100% quality inspection also performed on each device, which includes the following which look for missing stent marker: verification of final assembly based on the device evaluation, the dhr, the review of the process controls in place, and the results obtained from the returned stent, it is unlikely the lack of visualization of the distal marker is attributable to the device itself.It is possible for the user to have unintentionally missed visualizing the distal markers but still visualize the other markers present.During the procedure there are multiple radiopaque markers present, the distal markers on the stent markers are the least visible comparatively (due to their relatively small mass).Where the stent is placed (bone density, surrounding tissue) could potentially impact visibility of the distal markers.Additional controls are in place to mitigate the hazard in instructions for use (ifu).In step 13 of the ifu it states ¿continue advancing the delivery wire into the infusion catheter until the distal edge of the delivery wire reference marker (150 cm from the delivery wire distal tip) enters the introducer.Loosen the rhv locking ring, remove the introducer, and set it aside.Note: fluoroscopy may be used up to this point at the physician¿s discretion.As part of cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENTERPRISE2 4MMX30MM
• 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 ; 3035526892
• MDR Report Key: 19104783
• MDR Text Key: 340843543
• Report Number: 3008114965-2024-00392
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR403012
• Device Lot Number: 8269501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2023
• 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: MICROCATHETER (UNSPECIFIED BRAND)
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Race: Asian