MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX30MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR403012

Device Problem Defective Device (2588)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

As reported by the field, during a stent assist coil embolization to a dissecting aneurysm of initial portion of basilar artery, the physician planned to implant two stents in the lesion location.First an enterprise2 4mmx30mm intracranial stent (encr403012, 6610181) was released.Then a lvis stent (length: 22mm) inside it.The enterprise2 stent length was found to be only approximately 20-23mm compared to the lvis stent, while 30mm length was claimed in label.Additional information received indicated that the device was not manipulated in any way prior to appearing out of shape.The device was selected based on the instructions for use (ifu).The length was chosen by physician, after physician released the stent, it was found the stent was with the wrong size.There was no adverse consequence currently.The stent fully cover the aneurysm neck.The coils were maintained in the aneurysm sac.There were no procedural delays due to the event.

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).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) based upon further file review, it was noted that the correct product experience code (pec) is ¿stent - incorrect length-too short¿.Therefore, the complaint file has been updated and this supplemental med watch report is being submitted as a correction to reflect this change.The file remains usfda reportable.

Manufacturer Narrative

Product complaint (b)(4).Complaint conclusion: as reported by the field, during a stent assist coil embolization to a dissecting aneurysm of initial portion of basilar artery, the physician planned to implant two stents in the lesion location.First an enterprise2 4mmx30mm intracranial stent (encr403012, 6610181) was released.Then a lvis stent (length: 22mm) inside it.The enterprise2 stent length was found to be only approximately 20-23mm compared to the lvis stent, while 30mm length was claimed in label.Additional information received indicated that the device was not manipulated in any way prior to appearing out of shape.The device was selected based on the instructions for use (ifu).The length was chosen by physician, after physician released the stent, it was found the stent was with the wrong size.There was no adverse consequence currently.The stent fully covered the aneurysm neck.The coils were maintained in the aneurysm sac.There were no procedural delays due to the event.The medical imaging received was reviewed by cerenovus sr.Medical affairs director and the assessment reads as follows: ¿the description of the complaint is clear.The image shows two stents being placed in the posterior circulation.However, the conclusion that the enterprise 2 was shorter than expected can not necessarily been drawn from the images provided.It is known that braided stents (such as lvis and unlike the enterprise) do foreshorten upon deployment.The 22mm working length (for the double layer portion) of the 4.0mm diameter lvis device results in a total length of 26 mm (as per lvis ifu).The unconstrained opening that is required to go down to this actual 26 mm length is only possible in unconstrained conditions.This is not the case if the stent is deployed in the enterprise 2 stent.Moreover, the flaring ends of the lvis may further limit the expansion of the device even more.Given these considerations, the lvis may be longer than listed on the box due to limited expansion in the given situation.Hence, the 26 mm of the lvis maybe more than listed and the stents may look similar in size after deployment¿.The device remains implanted; 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 complaint 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.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: ENTERPRISE2 4MMX30MM
• 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: 17287520
• MDR Text Key: 318941555
• Report Number: 3008114965-2023-00480
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR403012
• Device Lot Number: 6610181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Race: Asian