MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL STENT - VASCULAR RECONSTRUCTION; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISE

Device Problems Activation Failure (3270); Migration (4003)

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

Event Date 04/29/2007

Event Type  malfunction  

Event Description

This complaint is from a literature source and the following citation was reviewed: pavlisa, goran, ozretic, david, rados, marko and pavlisa, gordana."migration of enterprise stent in treatment of intracranial aneurysms: a report of two cases" radiology and oncology, vol.43, no.4, 2009, pp.233-239.Https://doi.Org/10.2478/v10019-009-0022-z background and purpose: background.We present two patients with acutely ruptured complex aneurysms of the internal carotid artery, arising at the origin of the posterior communicating artery (pcoma).Case reports.The aneurysms in both patients had a wide neck and the closed-cell stent (enterprise) was delivered to assist in aneurysm coiling.In both patients an inadvertent migration of stent occurred, without periprocedural complications.Aneurysms were successfully embolized by endovascular coils.Cerenovus devices that were used in this study: qty 1 :prowler select plus 21 microcatheter ; qty 2: 4.5 mm x 22 mm enterprise stent.Non-cerenovus devices that were also used in this study: qty 1: 6 f guiding catheter (multipurpose, boston scientific neurovascular, fremont, ca, usa) ; qty 1: excel 0.014 inch microcatheter; qty 1: synchro 0.014 microguidewire (boston scientific, fremont, ca, usa); qty unknown: bare platinum guglielmi de-tachable coils (gdcs); qty 1: excelsior 10 microcatheter(boston scientific, fremont, ca, usa).Adverse event(s) and provided interventions associated with the enterprise stent: patient 1: intraprocedural stent migration to proximal ica, due to the angle of the vessel.The migration secured a more stable position to continue further coil embolization.Procedure was completed successfully.Patient 2: intraprocedural stent migration; the proximal part of the stent migrated to the aneurysm neck, while the distal part remained in the initial position in m1 segment of the middle cerebral artery.Event was attributed to the proximal part of the stent not completely opening after the microcatheter (prowler select plus 21) withdrawal.The stent position still allowed for successful coiling, and the aneurysm was embolized with 18 coils, with a minimal neck remnant.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source and the following citation was reviewed: pavlisa, goran, ozretic, david, rados, marko and pavlisa, gordana."migration of enterprise stent in treatment of intracranial aneurysms: a report of two cases" radiology and oncology, vol.43, no.4, 2009, pp.233-239.Https://doi.Org/10.2478/v10019-009-0022-z 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: the initial reporter phone: (b)(6).Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Movement of the stent away from the implant site after it has been deployed could lead to embolization, possibly ischemia or infarct.Additionally, the second case study attributes the event to an incomplete stent expansion, which also has the potential to lead to ischemia or infarct.In both cases, the procedures were completed successfully, however, if the event were to reoccur, this could result in patient harm.Since the events are considered life threatening that might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.The event is reportable to the us fda.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.

• Brand Name: STENT - VASCULAR RECONSTRUCTION
• 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: 18460678
• MDR Text Key: 332734360
• Report Number: 3008114965-2024-00012
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 6 F GUIDING CATHETER; BARE PLATINUM GUGLIELMI DE-TACHABLE COILS (GDCS); EXCEL 0.014 INCH MICROCATHETER; EXCELSIOR 10 MICROCATHETER; SYNCHRO 0.014 MICROGUIDEWIRE