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

Model Number	641CF3509
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
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.(b)(6).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.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.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 a stent-assisted coil embolization, the stent body of a 4.5mmd 22mml enterprise with no distal tip (enc452200, 5874652) detached in the unspecified microcatheter (mc) without expectation.The physician removed the microcatheter and stent system outside of the patient.The cerebral target position was lost.Then the physician switched to another new mc and stent system to complete the procedure.There was not patient injury reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).The product has been returned for evaluation and testing.However, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Product complaint # (b)(6).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 a stent-assisted coil embolization, the stent body of a 4.5mmd 22mml enterprise with no distal tip (enc452200, 5874652) detached in the unspecified microcatheter (mc) without expectation.The physician removed the microcatheter and stent system outside of the patient.The cerebral target position was lost.Then the physician switched to another new mc and stent system to complete the procedure.There was not patient injury reported.Only a portion of an unknown microcatheter was returned for evaluation.The unknown microcatheter catheter portion length is 4 cm.The portion of the microcatheter was inspected under an x-ray to verify if the stent of the eu ent4.5mmd 22mml wno dstl tp was stuck inside it, however, the x-ray analysis revealed that the stent was not stuck inside.The stent of the eu ent4.5mmd 22mml wno dstl tp was not returned for evaluation therefore an analysis cannot be performed.The account confirmed that the stent was not returned.Lake region medical did review the device history records (dhr) relative to the manufacturing, inspecting, and packaging of lot 5874652.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.With the information available and without the stent of the eu ent4.5mmd 22mml wno dstl tp, the reported customer complaint of ¿coil - deployment difficulty-premature/in microcatheter¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.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.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.

• Brand Name: EU ENT4.5MMD 22MML 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
• MDR Report Key: 11392406
• Report Number: 3008114965-2021-00107
• Device Sequence Number: 11083507
• Product Code: NJE
• UDI-Device Identifier: 10878528009525
• UDI-Public: 10878528009525
• 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,Followup
• Report Date (Section B): 02/16/2021

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: 06/28/2022
• Device Model Number: 641CF3509
• Device Catalogue Number: ENC452200
• Device Lot Number: 5874652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/18/2021; 04/14/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 04/05/2021; 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED MICROCATHETER