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

Catalog Number ENCR401600

Device Problems Difficult to Advance (2920); Activation Problem (4042)

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

Event Date 04/28/2022

Event Type  malfunction  

Event Description

As reported by the field, during the use of a 4mm x 16mm enterprise2 no tip intracranial neurovascular stent (encr401600, 6610143) was unable to open.The physician felt a little resistance when stent advanced within the unspecified microcatheter (mc).Distal markers of stent were unable to open, then doctor used a wire to massage the stent, but it did not work.A new competitive brand 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 has been discarded; therefore, no further investigation can be performed.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6610143.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.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.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).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Section b5: additional information received indicated that the introducer was not fully seated and secured in the hub.They were not able to torque the device.There was no evidence of physical material within the device.The resistance was encountered and the body/shaft.The microcatheter used was a headway 21 0.021.It was not necessary to remove the mc.The replaced stent was not the same size as the original one.The aneurysm being treated was at the internal carotid ophthalmic.There was no delay in the procedure due to the event.Complaint conclusion: as reported by the field, during the use of a 4mm x 16mm enterprise 2 no tip intracranial neurovascular stent (encr401600, 6610143) was unable to open.The physician felt a little resistance when stent advanced within the unspecified microcatheter (mc).Distal markers of stent were unable to open, the doctor used a wire to massage the stent, but it did not work.A new competitive brand stent was used to complete the surgery.There was no patient injury report.Additional information received indicated that the introducer was not fully seated and secured in the hub.They were not able to torque the device.There was no evidence of physical material within the device.The resistance was encountered and the body/shaft.The microcatheter used was a headway 21 0.021.It was not necessary to remove the mc.The replaced stent was not the same size as the original one.The aneurysm being treated was at the internal carotid ophthalmic.There was no delay in the procedure due to the event.The device was discarded; therefore, no further investigation can be performed.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6610143.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Deployment difficulty and resistance/friction of the delivery wire are known potential product failures associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.The instructions for use (ifu) warns that the delivery wire should not be torqued to gain access into the aneurysm.Continue advancing the delivery wire into the infusion catheter until the distal edge of the delivery wire reference marker (150 cm from the delivery wire distal tip) enters the introducer.Loosen the rhv locking ring, remove the introducer, and set it aside.Note: fluoroscopy may be used up to this point at the physician¿s discretion.Warns to not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.Assignment of root cause for the events remains speculative and inconclusive, based on the minimal information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation and vessel characteristics, may have contributed to the reported failure.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: 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14376427
• MDR Text Key: 300055558
• Report Number: 3008114965-2022-00334
• 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: 06/10/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: ENCR401600
• Device Lot Number: 6610143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• 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: HEADWAY21 0.021 MICROCATHETER; UNSPECIFIED MICROCATHETER