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 11/14/2022

Event Type  malfunction  

Event Description

The healthcare professional reported that the 67-year-old female patient presented with a c7 segment aneurysm on the left internal carotid artery (ica) underwent a stent-assisted coil embolization procedure.After the access was established during the procedure, a coil was ¿firstly filled in the aneurysm, then the microcatheter was in place¿ and the stent, a 4mm x 23mm enterprise 2 stent (encr402312 / 6920561) was partially released, then the coil ¿was continuously filled¿ until it completely filled the aneurysm.The physician released the stent completely and retracted the delivery system.It was found that the distal tip of the delivery wire broke in the patient, ¿and the procedure was completed.¿ a single procedure image was included in the complaint.The procedure was reportedly prolonged by about 10 minutes.The patient was sent to the intensive care unit (icu) for observation; and the patient was not fully awake at the time.The complaint reported that the procedure was completed and the patient was sent to the icu for observation; the patient was still not fully awake at the time.There was no information on whether there was medical or surgical intervention provided.The complaint included one procedure image that is pending independent physician review.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.Initial reporter name and address: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Based on complaint information, the device was not available to be returned for analysis.(b)(6) medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 6920561.The history record indicates this product was final inspection tested at (b)(6) medical and was determined to be acceptable.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.A manufacturing documentation review was performed.There is no indication that the event is related to the device manufacturing process.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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 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.

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(b)(4).The purpose of this mdr submission is to include the additional event information received on 20-dec-2022.The information also includes a correction to the age of the patient and the initial reporter phone.[additional information]: on 20-dec-2022, additional information was received.The information included a correction in the patient¿s age; it was originally reported that the patient is 67 years old.The patient is reported to be a 64-year-old female of han nationality.The information indicated that the patient is currently in good condition and has been discharged from the hospital; the patient in the intensive care unit (icu) three days for observation; it was reported that the patient¿s hospitalization was prolonged for two days.There was no medical and/or surgical interventional attempt to remove the distal tip of the delivery wire from the patient.Currently, there is no planned future treatment to address the fractured delivery wire.There was no vessel injury / damage related to the reported event.The information confirmed that there was no negative impact / patient consequence associated with the reported fractured delivery wire distal tip.Adequate flush was maintained through the concomitant prowler select plus microcatheter (606s255x / 30772065).There was no evidence of obstructed blood flow due to the reported event.The device appeared normal prior to being inserted into the patient.There was no resistance experienced while advancing the stent and stent delivery system through the concomitant microcatheter.Excessive force was not applied to the device during retraction of the delivery system after the stent was released.It was indicated that the 10-minute prolongation of the procedure was not considered clinically significant.E.1: initial reporter phone: (b)(6).Corrected sections: a.2: patient age at the time of event and e.1: initial reporter phone.Updated sections: a.2, a.5, a.6, b.4, e.1, g.3, g.6, h.2, h.6, h.10, h.11, and concomitant products.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.A.2: 2.Patient age at the time of event was originally reported as 67.It has been corrected to 64.E.1: the initial reporter phone was originally reported as: (b)(6).

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the independent physician review of the one procedure image that was included in the complaint file.The attached medical imaging was reviewed by (b)(6) (neuro interventionalist), on 04-dec-2022.The assessment reads as follows: ¿the description of the case is clear.One image in ap view is provided showing a coiled aneurysm on the right side with an enterprise stent in place.The distal tip of the delivery wire is in normal position in this image.The event description indicates the tip was not retrieved but from the information provided it is not possible to determine the ultimate location of the tip.The cause of this event cannot be determined from the image provided.¿ physician name and date reviewed: (b)(6) md, 04-dec-2022.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 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 15918780
• MDR Text Key: 306454982
• Report Number: 3008114965-2022-00755
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2022

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: ENCR402312
• Device Lot Number: 6920561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/04/2022; 12/20/2022
• Supplement Dates FDA Received: 12/14/2022; 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian