MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENTERPRISE2 4MMX23MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR402312

Device Problem Material Separation (1562)

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

Event Date 04/30/2023

Event Type  malfunction  

Event Description

As reported by the field, during a stent assist coil embolization to a m1 segment aneurysm of the left middle cerebral artery and after vascular access was established, the first coil was filled in the aneurysm.When the prowler select plus microcatheter (606s255x, lot unknown) was placed in target position, an enterprise2 4mmx23mm intravascular stent (encr402312, 7332340) was delivered to the microcatheter (mc).After 8 coils filled the aneurysm densely, the physician withdrew the microcatheter to release the stent and completed the surgery.The angiography revealed that distal tip (delivery wire) of the stent was remained in patient¿s body.The procedure was prolonged about 20 minutes.The patient was stable currently.Additional information received indicated that the vessel was ¿not very tortuous¿.It was confirmed that the delivery wire broke/ separate into two pieces.No additional intervention was performed in order to remove the distal tip left in the patient.There was no difficulty with advancing the stent through the microcatheter.The delivery wire was not reshaped prior to use in the patient.The stent was not torqued or rotated during the attempt to advance it in the microcatheter.The event did not result in a clinically significant delay in the procedure.

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).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.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).Section b5: two images and one video were received, and the review was made by an independent physician the results are as follow: the description of the case is clear and the problem has to do with the distal tip of the stent-pusher detached and remained in the patient.The two images and video support this.The cause is not clear from the description, nor from the images and further analysis of the pusher wire may be of benefit in finding the causative factor.Complaint conclusion: as reported by the field, during a stent assist coil embolization to a m1 segment aneurysm of the left middle cerebral artery and after vascular access was established, the first coil was filled in the aneurysm.When the prowler select plus microcatheter (606s255x, lot unknown) was placed in target position, an enterprise2 4mmx23mm intravascular stent (encr402312, 7332340) was delivered to the microcatheter (mc).After 8 coils filled the aneurysm densely, the physician withdrew the microcatheter to release the stent and completed the surgery.The angiography revealed that distal tip (delivery wire) of the stent was remained in patient¿s body.The procedure was prolonged about 20 minutes.The patient was stable currently.Additional information received indicated that the vessel was ¿not very tortuous¿.It was confirmed that the delivery wire broke/ separate into two pieces.No additional intervention was performed in order to remove the distal tip left in the patient.There was no difficulty with advancing the stent through the microcatheter.The delivery wire was not reshaped prior to use in the patient.The stent was not torqued or rotated during the attempt to advance it in the microcatheter.The event did not result in a clinically significant delay in the procedure.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.Two images and one video were received, and the review was made by an independent physician the results are as follow: the description of the case is clear and the problem has to do with the distal tip of the stent-pusher detached and remained in the patient.The two images and video support this.The cause is not clear from the description, nor from the images and further analysis of the pusher wire may be of benefit in finding the causative factor.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 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 4MMX23MM
• 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): CERENOVOUS,INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16920520
• MDR Text Key: 315448922
• Report Number: 3008114965-2023-00289
• 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: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 7332340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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 150/5CM
• Patient Age: 62 YR
• Patient Sex: Female