MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU 4.5X37MM STENT 12 MM DW TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENC453712

Device Problems Premature Activation (1484); Difficult to Remove (1528); Activation Problem (4042)

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

Event Date 05/12/2022

Event Type  malfunction  

Event Description

As reported by the field, during a stent assist coil embolization, a 4.5x37mm enterprise stent 12 mm dw tip (enc453712, 6920548) became impeded in an unspecified microcatheter (mc) and released outside of the patient¿s body.It was reported that during procedure, stent arrived in parent artery and released the distal end of the stent for about 5mm.The physician observed that the position of the stent was not appropriate, then he tried to retract it for adjusting, but felt some resistance.The stent was retracted into the microcatheter after several attempts.The doctor tried to release the stent again, but still felt resistance.The stent could not be released completely (could only release the distal end of the stent for about 2mm).The stent was withdrawn and found to be released on operation table.A new stent was used to complete the surgery.There was no patient injury report.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (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¿ as the reason for non-evaluation.If the device returns, a device investigation will be performed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.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 4.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.

Manufacturer Narrative

Product complaint #(b)(4).Section b5: additional information received indicated that no additional intervention was needed to remove the device from the patient.No excessive force was applied to the device.The system was used with the recommended microcatheter.They were able to torque the device.There was no evidence of physical material within the device.It was necessary to remove the mc with the enterprise.The target site being treated was the left middle cerebral artery.It was noted that the vessel was curved.There were no procedural delays due to the event.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2022-00388 and 3008114965-2022-00525.

Manufacturer Narrative

Product complaint #
=
> pc-001124122 updated sections on this medwatch: b4, d9, g3, g6, h2, h3, h6 and h10.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 assist coil embolization, a 4.5x37mm enterprise stent 12 mm dw tip (enc453712, 6920548) became impeded in a 150/5cm prowler select plus microcatheter (606s255x , 30686635 ) and released outside of the patient¿s body.It was reported that during the procedure, the stent arrived in the parent artery and released the distal end of the stent for about 5mm.The physician observed that the position of the stent was not appropriate, then he tried to retract it for adjusting, but felt some resistance.The stent was retracted into the microcatheter after several attempts.The doctor tried to release the stent again, but still felt resistance.The stent could not be released completely (could only release the distal end of the stent for about 2mm).The stent was withdrawn and found to be released on the operation table.A new stent was used to complete the surgery.There was no patient injury report.A non-sterile eu 4.5x37mm stent 12 mm dw tip was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, the stent was already detached from the unit, then it was inspected, and no abnormalities were found on it (i.E.No broken struts, no kinks).The delivery wire was also inspected, and it was found in good condition.The introducer was not returned for evaluation.The functional analysis could not be performed due to the stent was returned already detached from the unit.The stent must be still inside the introducer tube to perform the functional analysis.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.Due to the condition in which the device was received (stent was returned already detached from the unit), the customer complaint delivery wire, withdrawal difficulty-from vessel was not able to be evaluated, however, no damages were found in the device that contribute to the reported event, procedural factors may contribute to the device failure.The customer complaint regarding partial deployment of the stent could not be confirmed since in the inspection of the stent no damages were found on it, also no other abnormalities were found on the device that contribute to the complaint.It is possible that clinical and procedural factors, including device manipulation and vessel characteristics, may have contributed to the reported failure.The stent was received fully deployed, due to this condition the customer complaint regarding a premature deployment of the stent was able to be confirmed.A device history record evaluation was performed, and no non-conformances were identified.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to it should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do 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.Assignment of root cause for the events 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 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.

• Brand Name: EU 4.5X37MM 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14547554
• MDR Text Key: 300792273
• Report Number: 3008114965-2022-00388
• 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,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Catalogue Number: ENC453712
• Device Lot Number: 6920548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2021
• 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: UNSPECIFIED MICROCATHETER