MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS30150

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Stenosis (2263); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

This is 2 of 2 reports.Device remains implanted in patient.

Event Description

It was reported that there was development of intra stent stenosis in patient post procedure after implanting a stent (subject device).The issue was resolved without sequelae.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

Based on additional information received from the site on 22-dec-2020 clarified that the adverse event was not related to the device and it clarified that the adverse event first reported as related to the subject stent is now determined to be unrelated.Since there was no adverse event and no reported malfunction of the device that could have caused or contributed to an adverse event, this event does not meet reporting criteria anymore and the reportability will be changed from reportable to non-reportable with new awareness date of on 22-dec-2020.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported that there was development of intra stent stenosis in patient post procedure after implanting a stent (subject device).The issue was resolved without sequelae.No clinical consequences were reported to the patient due to this event.

• Brand Name: NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10977643
• MDR Text Key: 220494571
• Report Number: 3008881809-2020-00386
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS30150
• Device Lot Number: 19150473
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ECHELON GUIDEWIRE (MEDTRONIC); HYPERFORM BALLOON CATHETER (MEDTRONIC); NEUROFORM ATLAS STENT (STRYKER); PHENOM21 CATHETER (MEDTRONIC); SYNCHRO2 GUIDEWIRE (STRYKER); X-PEDION GUIDEWIRE (MEDTRONIC); ECHELON GUIDEWIRE (MEDTRONIC); HYPERFORM BALLOON CATHETER (MEDTRONIC); NEUROFORM ATLAS STENT (STRYKER); PHENOM21 CATHETER (MEDTRONIC); SYNCHRO2 GUIDEWIRE (STRYKER); X-PEDION GUIDEWIRE (MEDTRONIC)
• Patient Outcome(s): Other
• Patient Age: 40 YR