MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X22MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Model Number	641CF3575
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The stent was found kinked, meeting regulatory reporting criteria.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.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 embolization of aneurysm, a 4.5x22mm enterprise intracranial stent 12mm dw tip (enc452212, 6357990) impeded in introducer.It was reported that before the procedure, the physician opened the package, observed stent was impeded in introducer and could not be pushed out, it was not used on the patient.The physician switched to another new device to complete the procedure.There was no injury reported.Additional information received indicated that they were not able to move the device at all due to the resistance.Nothing was noted to be obstructing the introducer sheath.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.There was no excessive force applied to the device.A visual analysis of the photo received observed that the stent of the eu 4.5x22mm stent 12 mm dw tip could be noted inside of the introducer, however due to the picture no damages could be noted on it.Only one part of the introducer can be seen in the picture and no damages could be noted.The delivery wire could not be seen in the picture.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6357990.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.A non-sterile eu 4.5x22mm stent 12 mm dw tip was received inside of a pouch.The device was inspected and, guidewire was observed out of the introducer.Stent was found still inside introducer.Whitish residues were observed at the proximal end of the introducer, presumable saline solution residues.The device was inspected under a microscope, and proximal ends of the stent were observed uneven.Further inspection revealed that stent was bent and one of the proximal ends was tangled in the middle of the stent.The functional test could not be performed due the damage observed at the stent.It was attempted to move the stent inside the introducer; however, it was not possible to advance or retract.A visual analysis of the returned device revealed that the guidewire was out of the introducer, but the stent was still inside.Additionally, whitish residues were observed at the proximal end of the introducer indicating that stent had been flushed.Microscopic inspection revealed that stent was bent inside the introducer: one of the proximal ends was observed tangled and bent towards the middle part of the stent, causing the impeded condition.It was not possible to advance or retract the stent due to the damage observed on it.As a result, the functional test could not be performed.The picture received shows the guidewire coming out of the introducer, however, this neither provides further evidence to assign a root cause.Although the functional test could not be performed, the conditions described above could be the result of the maneuver during the advancement or retrieval of the device.Based on the finding during the analysis, the customer complaint was confirmed.A device history record evaluation was performed, and no non-conformances were identified.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: if resistance is met during manipulation, determine the cause of resistance before proceeding.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.
Event or Problem Description
As reported by the field, during a stent-assisted embolization of aneurysm, a 4.5x22mm enterprise intracranial stent 12mm dw tip (enc452212, 6357990) impeded in introducer.It was reported that before the procedure, the physician opened the package, observed stent was impeded in introducer and could not be pushed out, it was not used on the patient.The physician switched to another new device to complete the procedure.There was no injury reported.Additional information received indicated that they were not able to move the device at all due to the resistance.Nothing was noted to be obstructing the introducer sheath.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during device advancement.There was no excessive force applied to the device.Based on the analysis of the device received, the stent was found kinked.

• Brand Name: EU 4.5X22MM STENT 12 MM DW TIP
• 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13440518
• Report Number: 3008114965-2022-00075
• Device Sequence Number: 14529152
• Product Code: NJE
• UDI-Device Identifier: 10878528009495
• UDI-Public: 10878528009495
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2022

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: 05/28/2023
• Device Model Number: 641CF3575
• Device Catalogue Number: ENC452212
• Device Lot Number: 6357990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2021
• 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 Sex: Unknown