MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 22MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Model Number 641CF3509

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
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> pc (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during an intracranial stent assist aneurysm embolization, while advancing a 4.5mm enterprise stent (enc452200, 11195613), the stent deployed prematurely within the unknown microcatheter (mc).The physician withdrew the stent system and microcatheter outside of the patient.Changed to a new stent and microcatheter to complete the procedure.There was no patient injured reported.Based on the photo provided, it can be determined that the stent could be noted separated from the delivery wire and it remains inside of the introducer.No damages could be observed on the stent, the delivery wire could not be noted on the pictures, also one picture of the outer box was received.Further investigation was performed on the non-sterile unit eu ent4.5mmd 22mml wno dstl tp was received inside of a pouch.The device was inspected, and it was noted that the stent is detached from the rest of the device inside the introducer, the delivery wire and the introducer were found in good normal conditions.The functional analysis could not be performed due to the stent was returned detached from the rest of the device inside the introducer.It is necessary that the stent is still inside of the introducer tube to perform the functional analysis.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 11195613 the history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The complaint reported by the customer ¿stent - deployment difficulty-premature/in microcatheter¿ could not be duplicated since during the analysis it was noted that the stent was returned detached from the rest of the device inside the introducer.Although the stent is detached from the rest of the device, there is no evidence that the detach condition was originated in the microcatheter or rhv since only the eu ent4.5mmd 22mml wno dstl tp was returned for evaluation.Based on the detach condition noted on the stent, the customer complaint was confirmed, however, the exact time when this occurred could not be conclusively determine.The detached condition noted on the stent appear to might have been caused by the handling of the device at the time of the procedure, however, this cannot conclusively determine.Neither the analysis nor the mre suggest that the failure reported by the custumer could be related to the manufacturing process.Premature stent deployment in microcatheter is a known potential complication associated with the use of the enterprise 2 vascular reconstruction device in the intracranial arteries.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned system.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

Event Description

As reported by the field, during an intracranial stent assist aneurysm embolization, while advancing a 4.5mm enterprise stent (enc452200, 11195613), the stent deployed prematurely within the unknown microcatheter (mc).The physician withdrew the stent system and microcatheter outside of the patient.Changed to a new stent and microcatheter to complete the procedure.There was no patient injured reported.A device photo was provided.

• Brand Name: EU ENT4.5MMD 22MML WNO DSTL TP
• 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: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10770888
• MDR Text Key: 214147869
• Report Number: 3008114965-2020-00490
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10878528009525
• UDI-Public: 10878528009525
• 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
• Report Date: 10/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: 641CF3509
• Device Catalogue Number: ENC452200
• Device Lot Number: 11195613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2019
• 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: UNKNOWN MICROCATHETER
• Patient Age: 31 YR