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

Catalog Number ENCR401600

Device Problem Component Missing (2306)

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

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.The product analysis lab reviewed the photos included in the complaint.The review is documented below.[photo review]: three photos were attached to the complaint file; in two of them, only the outer package was shown.The third photo shows the delivery system partially inside of the hoop dispenser; only the introducer distal tip was noted to be outside.The stent was noted to be already detached from the unit, and no visible damages were noted in the delivery wire.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The issue regarding a stent component being missing was confirmed since the stent was noted to be no longer attached to the delivery system; however, the exact time when this occurred cannot be determined.This investigation was performed based only on the photo provided.The complaint device was returned and received on 28-aug-2023.The product investigation is documented below.Investigation summary: a non-sterile 4mm x 16mm enterprise 2 vascular reconstruction device was received contained in the decontamination pouch.Visual inspection was performed.It was noted that as per the event description, the stent component was missing from the delivery system.The delivery wire was found outside of the introducer.No appearance of damage was observed on the returned components.Microscopic inspection revealed that the delivery wire was broken at the distal end.The positioning coil and the retraction bump were missing from the delivery wire.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8028686.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The issue regarding a stent component being missing was confirmed since the stent was noted to be no longer attached to the delivery system; however, since this was manipulated outside of its original package, the issue reported cannot be traced to the assembly of the device.Additionally, the device history record indicates that the product was final inspection tested at the manufacturing site and was determined to be acceptable and it met the released criteria prior to shipment.It cannot be determined if the stent component was originally missing from the enterprise system, or if the stent was detached from the unit.It is possible that pre-procedural factors, that cannot be determined, may have contributed to the failure mode reported.The broken condition of the delivery wire was not originally reported, and the exact time when this condition occurred cannot be determined.With the limited information available and the evidence obtained from the device inspection, there is no clear insight into the root cause and/or exact contributing factors that may have resulted in the broken condition.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: ¿ do not use the codman enterprise 2 vascular reconstruction device if any component appears damaged or missing.¿ confirm that the delivery wire does not move relative to the introducer during removal of the codman enterprise 2 vascular reconstruction device from the dispenser hoop.¿ confirm that the tip of the delivery wire is entirely within the introducer.Based on the review of the manufacturing documentation, there is no indication that the event is related to the device manufacturing process.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.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.

Event Description

The healthcare professional reported that before the start of an endovascular embolization procedure, the physician opened the device packaging for the complaint device, a 4mm x 16mm enterprise 2 vascular reconstruction device (vrd) (encr401600 / 8028686) for inspection.The stent body was noted to be absent from the stent delivery system.A new stent was used as replacement to complete the procedure.There was no report of any negative patient impact.Three (3) photos were included in the complaint.Two (2) of the photos are of the device packaging.The third photo is of the delivery system.On 10-jul-2023, additional information was received.The information indicated that the stent component did not become prematurely detached during the removal of the device from the packaging or during procedure prep.There was no damage noted on the packaging.The device was returned for evaluation and analysis on 28-aug-2023.The product investigation completed on 04-sep-2023.Based on the completed product investigation, this event has been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.

• 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): CERENOVUS INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17686225
• MDR Text Key: 323223842
• Report Number: 3008114965-2023-00636
• 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
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• 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: 8028686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• 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