MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX16MM NO TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR401600

Device Problems Material Separation (1562); Failure to Advance (2524)

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

Event Date 01/31/2023

Event Type  malfunction  

Event Description

As reported by the field, during a stent assist coil embolization, an enterprise2 4mmx16mm no tip intracranial stent (encr401600, 7107420) became impeded proximal of an unspecified microcatheter (mc) and could not advance any more.The physician retracted the stent and observed that the delivery wire of the stent was broken.A new stent was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury report.Additional information was received indicating that the mc was a prowler select plus (606s255x, 30727353).The mc did not kink or bent.No additional intervention was needed to remove the device from the patient.There was no evidence of fragments remaining in the patient.The distal tip of the enterprise was not re-shaped prior to use.There was no excessive force applied to the device.There was no procedural delay due to the event.The target vessel/site being treated was the right side of the internal carotid artery ica-c6.

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¿ 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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4mm x 16mm enterprise 2 vascular reconstruction device was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the stent component was not returned for evaluation.The delivery wire was observed still inside the introducer.No appearance of damage was observed.The delivery wire was observed under the microscope.Under magnification, the distal end was observed broken near the retraction bump.No other damages were found on the delivery wire.The introducer was found in good, normal condition (i.E., no kinks, bends, or fractures).The complaint regarding the stent being impeded in the microcatheter could not be tested due to the stent being detached from the delivery wire.The stent must be still attached to the delivery wire and inside the introducer tube to perform the functional analysis.It is possible that an adequate flush had not been done; without an adequate flush, issues such as resistance between the stent and the microcatheter can arise.However, due to the broken appearance of the delivery wire, the complaint regarding the delivery wire being broken was confirmed.At this time, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.Lake regions investigation results: a review of the device history records of the specimen device did not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Analysis of the returned specimen revealed no manufacturing anomaly.The delivery wire presented a fracture/shear of the core wire an unknown distance from the distal tip.As part of the investigation, a characterization of the fracture/shear was completed.The type of markings observed indicate that there was a cutting event in the field.The investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided and the evidence presented, it appeared that handling and/or clinical factors have contributed to the event as reported.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.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use (ifu) does contain the following cautions: 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.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: ENTERPRISE2 4MMX16MM NO 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16395934
• MDR Text Key: 310228172
• Report Number: 3008114965-2023-00118
• 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: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR401600
• Device Lot Number: 7107420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• 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: PROWLER SELECT PLUS MICROCATHETER
• Patient Age: 67 YR
• Patient Sex: Female