MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKENTERPRISE2; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Section b.3: date of event: the date of the event is not known.Section d.4: the product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.Section e.1: information related to initial facility name, initial reporter name, phone and email address of the initial reporter are not available.Section h.4: the device manufacture date is not known as the device lot number is not available.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.An unknown enterprise device was returned to cerenovus for evaluation.However, the device could not be matched with any complaint record.There is no additional information as to the issue experienced with this device, or its relationship with a procedure.Upon receiving the device, a visual inspection was received, and it was found that only the delivery wire was returned.The distal end of the positioning coil was found missing.The introducer and stent were not returned.Microscopic inspection was performed, and the proximal end of the proximal coil was found detached from the delivery wire.Several kinked conditions were noted along the entire length of the proximal coil.No further investigation is being conducted as there is no alleged quality issue against the enterprise system.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 damages found on the delivery wire.This investigation is considered complete at this time; if additional information is received at a later time, this investigation will be updated, and further actions can be taken as needed.As part of cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.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

On (b)(6) 2023, an enterprise stent device was received, however, there was no complaint can be found to associate the return device with.The complaint device underwent evaluation and analysis.The product investigation completed on (b)(6) 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: UNKENTERPRISE2
• 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: 17784576
• MDR Text Key: 323871430
• Report Number: 3008114965-2023-00676
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2023
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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