MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX16MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR401612

Device Problem Component Missing (2306)

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

Event Date 12/20/2023

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 a stent assist coil embolization, after coils were filled in aneurysm, an enterprise2 4mmx16mm intracranial stent (encr401612, 7682989) was placed in appropriate position.The physician pushed the deliver wire to release the stent, but the stent markers could not be found under the ray, then withdrew the device to push the deliver wire again and there were still no markers.The physician examined the patient's intracranial carotid artery and operating table, no stent body was found, then retracted the deliver wire to microcatheter (other brand) and removed it with the microcatheter together out of the patient¿s body.The stent body was noted to be absent from the stent delivery system.A new stent was switched to complete the surgery with the same microcatheter.There was no patient injury.Additional information received on 09-jan-2024 indicated that the stent did not prematurely deploy.No additional intervention was needed due to the event.There was no severe vascular tortuosity at the target site.No excessive force was applied to the device.There were no procedural delays due to the event.The device was prepped as per the instructions for use.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h10.Complaint conclusion: as reported by the field, during a stent assist coil embolization, after coils were filled in aneurysm, an enterprise2 4mmx16mm intracranial stent (encr401612, 7682989) was placed in appropriate position.The physician pushed the deliver wire to release the stent, but the stent markers could not be found under the ray, then withdrew the device to push the deliver wire again and there were still no markers.The physician examined the patient's intracranial carotid artery and operating table, no stent body was found, then retracted the deliver wire to microcatheter (other brand) and removed it with the microcatheter together out of the patient¿s body.The stent body was noted to be absent from the stent delivery system.A new stent was switched to complete the surgery with the same microcatheter.There was no patient injury.Additional information received on 09-jan-2024 indicated that the stent did not prematurely deploy.No additional intervention was needed due to the event.There was no severe vascular tortuosity at the target site.No excessive force was applied to the device.There were no procedural delays due to the event.The device was prepped as per the instructions for use.One 4.0mm x 16mm enterprise®2 stent system was received.The delivery system was inside the introducer tube.The dispenser hoop was not returned for evaluation.Visual inspection was conducted, and no appearance of damage was observed.Under magnification, it was confirmed that the stent component was not attached to the delivery wire.Residues of saline solution were adhered to the proximal marker of the delivery wire.The delivery wire and introducer components were subjected to dimensional analysis and all measurements were found to be within specification including those specifications that control the attachment and delivery of the stent.Therefore, device failure is not suspected to be a contributing factor.The device history records (dhr) related to the manufacturing, inspection, and packaging of lot 7682989 indicate this product passed final inspection and was determined to be acceptable.Please note, final inspection requires verification of the stent.As part of the manufacturing process, there is a 100% in-process inspection that requires verification of the marker position and marker band alignment on the stent.The inspection also requires visual verification of the strut integrity of the stent and verification that the stent can move in the introducer.There is also a 100% inspection performed by quality after manufacturing.The 100% quality inspection consists of verification of marker band position on the stent and visual inspection for strut integrity of the stent.A review of the dhr of the impacted device verifies this inspection was performed for the affected lot.Therefore, no capa activity is proposed at this time.Based on the evidence obtained from the returned device, it was determined that the stent component was not attached to the delivery wire.However, since this device had been manipulated outside of their original packaging, the issue reported cannot be traced to the assembly of the device.It is unlikely that the stent component was originally missing from the enterprise system based on the dhr and review of the process controls in place.It is possible that pre-procedural factors may have contributed to the failure mode reported.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) do contain the following recommendations: carefully place the dispenser hoop into the sterile field.Remove the delivery wire from the clip on the dispenser hoop.Grasp the proximal end of the introducer and the delivery wire at the point where it exits the introducer.Hold wire and introducer together to prevent stent movement.Remove the cerenovus enterprise vascular reconstruction device and delivery system from the dispenser hoop.Do not partially deploy the stent from the introducer.Confirm that the delivery wire does not move relative to the introducer during the removal of the cerenovus enterprise vascular reconstruction device and delivery system from the dispenser hoop.Confirm the tip of the delivery wire is entirely within the introducer.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENTERPRISE2 4MMX16MM
• 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: 18476547
• MDR Text Key: 333094548
• Report Number: 3008114965-2024-00022
• 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,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR401612
• Device Lot Number: 7682989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2022
• 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: UNSPECIFIED MICROCATHETER.
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 48 KG