MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 14MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number	ENC451400
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional 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.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.The company is seeking this information through the event investigation.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 or Problem Description
As reported by the field, during an endovascular embolization, an eu ent4.5mmd 14mml wno dstl tp intracranial stent (enc451400, 8337176) was placed in target site and started to release.The physician could not observe the stent positioning marker and the stent distal markers.The doctor retracted the stent and gave up implanting a stent and completed the surgery.Additional event information received on 30-jul-2024 indicated that the radiopaque of device was worse than expected.There were no procedural delays due to the event.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by the field, during an endovascular embolization, an eu ent4.5mmd 14mml wno dstl tp intracranial stent (enc451400, 8337176) was placed in target site and started to release.The physician could not observe the stent positioning marker and the stent distal markers.The doctor retracted the stent and gave up implanting a stent and completed the surgery.Additional event information received on 30-jul-2024 indicated that the radiopaque of device was worse than expected.There were no procedural delays due to the event.A non-sterile eu ent4.5mmd 14mml wno dstl tp intracranial stent 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.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.A device history record (dhr) was performed and it indicated this product was final inspection tested at lake region medical and was determined to be acceptable.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.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.

• Brand Name: EU ENT4.5MMD 14MML WNO DSTL TP
• Common Device Name: 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: 19918247
• Report Number: 3008114965-2024-00776
• Device Sequence Number: 12786078
• Product Code: NJE
• UDI-Device Identifier: 10878528009457
• UDI-Public: (01)10878528009457(11)230619(17)250528(10)8337176
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: H60001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2025
• Device Catalogue Number: ENC451400
• Device Lot Number: 8337176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 60 KG