MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 24MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS40240

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

Patient Problem Infarction, Cerebral (1771)

Event Date 04/28/2017

Event Type  Injury  

Manufacturer Narrative

Subject device remains implanted.

Event Description

It was reported that during coil-assisted stenting with the stent retriever (subject device) for an aneurysm located at the midline anterior communicating artery, the patient suffered an ischemic stroke.The patient was confused with aphasia due to multiple ischemic lesion related to the catheterization.According to the physician, the event was related to stent delivery system.The adverse event was resolved 5 days post-procedure without sequelae.

Event Description

It was reported that during coil-assisted stenting with the stent retriever (subject device) for an aneurysm located at the midline anterior communicating artery, the patient suffered an ischemic stroke.The patient was confused with aphasia due to multiple ischemic lesion related to the catheterization.According to the physician, the event was related to stent delivery system.The adverse event was resolved 5 days post-procedure without sequelae.

Manufacturer Narrative

D4: expiration date: updated h4: manufacturing date: updated 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.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.The reported events are known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication will be assigned to this event.

• Brand Name: NEUROFORM ATLAS 4.0MM X 24MM 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: 9866459
• MDR Text Key: 184508741
• Report Number: 3008881809-2020-00072
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: M003EZAS40240
• Device Lot Number: 19261942
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR