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

Model Number	M003STAS30150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a clinical trial the patient suffered a cerebral aneurysm rupture 10 months post procedure with relation to the subject stent per clinical endpoint committees (cec).The patient was hospitalized and given medication for treatment.The event resolved with no effects to the patient.No further information is available.
Additional Manufacturer Narrative
Device remains implanted in patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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 event occurred post-treatment of a non-target right pericallosal artery aneurysm with two subject stents and non-stryker coils.There was no indication that the stent device contributed to the reported aneurysm rupture.The patient aneurysm rupture reported in this investigation is listed as known complication in the device directions for use (dfu).The reported event is known and an anticipated complication to these types of procedures and patient condition, and are listed as such in the device dfu, therefore an assignable cause classification of anticipated procedural complication will be assigned to this complaint.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported in a clinical trial the patient suffered a cerebral aneurysm rupture 10 months post procedure with relation to the subject stent per clinical endpoint committees (cec).The patient was hospitalized and given medication for treatment.The event resolved with no effects to the patient.No further information is available.

• Brand Name: NEUROFORM ATLAS 3.0MM X 15MM NO TIP- HDE
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12886765
• Report Number: 3008881809-2021-00498
• Device Sequence Number: 4828501
• Product Code: NJE
• UDI-Device Identifier: 07613252656005
• UDI-Public: 07613252656005
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: H020002/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2023
• Device Model Number: M003STAS30150
• Device Catalogue Number: M003SZAS30150
• Device Lot Number: 20471428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATLAS STENT (STRYKER); COIL (UNKNOWN)
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American