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 09/24/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter phone: (b)(6).The medical imaging was reviewed by cerenovus sr.Medical affairs director, dr.(b)(6).(neurointerventionalist), on (b)(6) 2022.The assessment reads as follows: ¿the event description highlights the problem encountered.There is no mentioning of whether something happened to the device during placement (eg.Friction in the catheter etc.).The distal portion of the enterprise2 is open whereas the proximal markers seem clumped together.The wire seems to be discontinuous, but the actual point of breakage is not discernable in the image (1 direction) and the pusherwire is retrieved.The cause of the break cannot be deducted from this image¿.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.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

It was reported that a patient underwent stent-assisted coil embolization of a ruptured posterior communicating artery (pca) aneurysm with an enterprise2 4mm x 23mm (encr402312/6976992).During the procedure, the physician was able to release the stent in the target position, but it was observed that the delivery wire had broken and could not be removed, thus remaining in the patient body.A stent solitaire ab (medtronic) had to be implanted in the patient to complete the surgery.The procedure was prolonged for about 20 minutes.Follow-up visit after one week showed that the patient was stable.A procedural medical imaging was provided and forwarded to cerenovus senior medical director (neurointerventionalist) for review.

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 on 01-november-2022 from the sales rep indicated that the distal tip of the enterprise was not re-shaped prior to use nor excessive force been applied to the device.The device was examined prior to use and was used with the recommended microcatheter.It was reported that the event resulted in a 20min delay to the procedure but per the physician it was not clinically significant.Details on age and gender were added above.There is no new information that alters the previous file type, coding, and/or reportability determinations.Complaint conclusion: it was reported that a 42-year-old female patient underwent stent-assisted coil embolization of a ruptured posterior communicating artery (pca) aneurysm with an enterprise2 4mm x 23mm (encr402312/ unknown lot).During the procedure, the physician was able to release the stent in the target position, but it was observed that the delivery wire had broken and could not be removed, thus remaining in the patient body.A stent solitaire ab (medtronic) had to be implanted in the patient to complete the surgery.The procedure was prolonged for about 20 minutes.Follow-up visit after one week showed that the patient was stable.Medical imaging was reviewed and reviewed by the cerenovus sr.Medical affairs director on 24-oct-2022.The assessment reads as follows: ¿the event description highlights the problem encountered.There is no mentioning of whether something happened to the device during placement (eg.Friction in the catheter etc.).The distal portion of the enterprise2 is open whereas the proximal markers seem clumped together.The wire seems to be discontinuous, but the actual point of breakage is not discernable in the image (1 direction) and the pusherwire is retrieved.The cause of the break cannot be deducted from this image¿.Additional information was received on 1 november 2022 from the sales rep.Summary of additional information provided: distal tip of the enterprise was not re-shaped prior to use nor excessive force been applied to the device.The device was examined prior to use and was used with the recommended microcatheter.It was reported that the event resulted in a 20min delay to the procedure but per the physician it was not clinically significant.Details on age and gender were added above.The device remains implanted in the patient, 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.A fractured and separated wire could embolize resulting in ischemia or infarct.In addition, the patient underwent an additional surgical intervention by placing a second stent.Therefore, this event meets mdr reportability criteria.The file will be re-reviewed if additional information is received at a later date.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 events were 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): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15698956
• MDR Text Key: 302692221
• Report Number: 3008114965-2022-00687
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCR402312
• Device Lot Number: 6976992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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: STENT SOLITAIRE AB (MEDTRONIC)
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female