MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 15MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS40150

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

Subject device not available.

Event Description

It was reported that during stent-assisted coiling procedure for an aneurysm located in the right internal carotid artery (ica) posterior communicating junction, during the navigation of the stent (subject device) within the microcatheter (non-stryker device) and just at the beginning of the deployment (unsheathing technique), the operator lost position and the microcatheter slipped into the aneurysmal sac with the first cell of the subject stent partially out of the microcatheter tip.The stent and the microcatheter were removed as one unit from the body without any harm to the patient.A second stent was deployed successfully.According to the physician, the navigation was easy but the catheter was not in a stable position due to the anatomy; the vessels were moderately tortuous, but the patient presented an atherosclerotic stenosis au the right ica (at the level of the bulb; stenosis between 50 and 75% according to nacset criteria).

Manufacturer Narrative

Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The intended use for the device was for treatment.The reported complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.

Event Description

It was reported that during stent-assisted coiling procedure for an aneurysm located in the right internal carotid artery (ica) posterior communicating junction, during the navigation of the stent (subject device) within the microcatheter (non-stryker device) and just at the beginning of the deployment (unsheathing technique), the operator lost position and the microcatheter slipped into the aneurysmal sac with the first cell of the subject stent partially out of the microcatheter tip.The stent and the microcatheter were removed as one unit from the body without any harm to the patient.A second stent was deployed successfully.According to the physician, the navigation was easy but the catheter was not in a stable position due to the anatomy; the vessels were moderately tortuous, but the patient presented an atherosclerotic stenosis au the right ica (at the level of the bulb; stenosis between 50 and 75% according to nacset criteria).

• Brand Name: NEUROFORM ATLAS 4.0MM 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 ; IE NA
• MDR Report Key: 10131494
• MDR Text Key: 194661065
• Report Number: 3008881809-2020-00169
• 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: study
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: M003EZAS40150
• Device Lot Number: 19417911
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/08/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEADWAY MICROCATHETER (MICROVENTION INC.)
• Patient Age: 63 YR