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

Catalog Number ENC452212

Device Problems Premature Activation (1484); Difficult to Advance (2920)

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

Event Date 10/26/2023

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, an eu 4.5x22mm intracranial stent 12 mm dw tip (enc452212, 7632761) encountered some resistance in y connector.The physician retracted the stent and it was released without intention.The stent body was separated prematurely from the delivery wire.The physician switched to a new stent to complete the surgery.The unspecified microcatheter was not replaced.There was no patient injury reported.Additional information received on 31-oct-2023 indicated that they were able to move the device and the device was able to torque.There was no evidence of physical material within the device.A sychro14 guide wire was successfully used with the concomitant device prior to the encountered resistance.The mc did not kink or bent.There were no procedural delays due to the event.The tip of the introducer sat correctly in the rhv and microcatheter hub.The introducer was placed securely in the hub prior to attempting to advance the delivery wire.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a stent assist coil embolization, an eu 4.5x22mm intracranial stent 12 mm dw tip (enc452212, 7632761) encountered some resistance in y connector.The physician retracted the stent and it was released without intention.The stent body was separated prematurely from the delivery wire.The physician switched to a new stent to complete the surgery.The unspecified microcatheter was not replaced.There was no patient injury reported.Additional information received on 31-oct-2023 indicated that they were able to move the device and the device was able to torque.There was no evidence of physical material within the device.A sychro14 guide wire was successfully used with the concomitant device prior to the encountered resistance.The mc did not kink or bent.There were no procedural delays due to the event.The tip of the introducer sat correctly in the rhv and microcatheter hub.The introducer was placed securely in the hub prior to attempting to advance the delivery wire.The device was discarded; therefore, no further investigation can be performed.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.With the information available and without the product available for analysis, the reported customer complaints 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.The instructions for use (ifu) contain the following recommendations: ¿ do not apply undue force if resistance is encountered at any point during stent manipulation.¿ withdraw the unit and advance to a new one.¿ if resistance is felt while recapturing the stent, do not continue to recapture the device.¿ withdraw the infusion catheter slightly to unsheathe the stent (without exceeding the recapture limit), and then attempt to recapture the stent again.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 4.5X22MM STENT 12 MM DW TIP
• 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: 18039584
• MDR Text Key: 328486649
• Report Number: 3008114965-2023-00790
• 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
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENC452212
• Device Lot Number: 7632761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• 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: SYCHRO14 GUIDE WIRE.; UNSPECIFIED MICROCATHETER.