MAUDE Adverse Event Report: ENTERPRISE2 4MMX16MM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENCR401612

Device Problems Retraction Problem (1536); Activation Problem (4042)

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

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.(b)(6).The device remains implanted; therefore, no further investigation can be performed.(b)(6) medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 5964691.The history records indicate this product was final inspection tested at (b)(6) 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.The company is seeking this information through the event investigation.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

As reported by the field, during surgery of stenotic slow closed patency, the marker of an enterprise2 4mmx16mm intracranial neurovascular stent (encr401612, 5964691) became stuck in the delivery system.It was not able to be pulled out, stent moves while pulling.Additional information received clarified that one marker of the proximal stent was stuck in delivery wire, as the delivery system moved, the stent moved together.The physician adjusted it and the stent was finally separated from delivery system and released in the target position.The delivery system and microcatheter were withdrawn and there was no report of patient injury.The device was not impeded in the microcatheter.It was not necessary to replace the microcatheter.There was no damage to the stent markers.There was no stent fracture.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information received on 21-oct-2021 indicated that it was not necessary to remove the microcatheter.The system was used with the recommended microcatheter.Neither the device nor the concomitant device (s) appears to be damaged.An adequate continuous flush was maintained through the microcatheter.The delivery wire and microcatheter were gently pulled back and observed one maker was stuck in the delivery wire.An image was provided.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: event description updated with additional information received on 21-oct-2021: as reported by the field, during surgery of stenotic slow closed patency, the marker of an enterprise2 4mmx16mm intracranial neurovascular stent (encr401612, 5964691) became stuck in the delivery system.It was not able to be pulled out, stent moves while pulling.Additional information received clarified that one marker of the proximal stent was stuck in delivery wire, as the delivery system moved, the stent moved together.The physician adjusted it and the stent was finally separated from delivery system and released in the target position.The delivery system and microcatheter were withdrawn and there was no report of patient injury.The device was not impeded in the microcatheter.It was not necessary to replace the microcatheter.There was no damage to the stent markers.There was no stent fracture.Additional information received on 21-oct-2021 indicated that it was not necessary to remove the microcatheter.The system was used with the recommended microcatheter.Neither the device nor the concomitant device (s) appears to be damaged.An adequate continuous flush was maintained through the microcatheter.The delivery wire and microcatheter were gently pulled back and observed one maker was stuck in the delivery wire.The device remains implanted; therefore, no further investigation can be performed.One picture was received, and the review was made by an independent physician and the results are shown bellows: from the description it seems as if the enterprise ii did not detach from the pusher wire in the most proximal portion.It is unclear what triggered the final release of the device but the movement back and forth, which normally also engages touching the tip of the microcatheter, may have caused this and is the best way of overcoming non-detachment.The image provided by the site seems to be taken after the event and does not provide any insights into the cause of the initial non-detachment.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 5964691.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.With the information available and without the product available for analysis, the reported customer complaint of ¿deployment difficulty and withdrawal difficulty¿ 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.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation/interaction, vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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 4MMX16MM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• MDR Report Key: 12487454
• MDR Text Key: 271895297
• Report Number: 1226348-2021-00055
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Catalogue Number: ENCR401612
• Device Lot Number: 5964691
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• 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