MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SZAS30210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the first of 2 reports.The event in this report is related to the event already reported in mfr report # 3008881809-2018-00299.Subject device remains implanted.
Event or Problem Description
It was reported that a patient was successfully treated by stent-assisted coil embolization of an unruptured aneurysm located at the basilar apex.More than 8 month-post-procedure, the patient suffered right-sided weakness.The issue is ongoing.Medication was required.According to the clinical events committee (cec), the right-sided weakness was related to the procedure and to the atlas stents (subject device).According to the site, the right-sided weakness was related to pre-existing condition/co-morbidity with a large basilar aneurysm swelling, causing pressure on brainstem per site.
Additional Manufacturer Narrative
Duplicate rationale: all information regarding patient 110-013 have been included in mfr report # 3008881809-2018-00299.Additional information regarding the details of the neurological symptoms for patient 110-013 as ¿right sided weakness¿ (ae#11) filed in this report is a duplicate of mfr report # 3008881809-2018-00299.Therefore this mfr report # will be closed as duplicate.
Event or Problem Description
It was reported that a patient was successfully treated by stent-assisted coil embolization of an unruptured aneurysm located at the basilar apex.More than 8 month-post-procedure, the patient suffered right-sided weakness.The issue is ongoing.Medication was required.According to the clinical events committee (cec), the right-sided weakness was related to the procedure and to the atlas stents (subject device).According to the site, the right-sided weakness was related to pre-existing condition/co-morbidity with a large basilar aneurysm swelling, causing pressure on brainstem per site.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7704657
• Report Number: 3008881809-2018-00313
• Device Sequence Number: 2771448
• Product Code: NJE
• UDI-Device Identifier: 07613252656159
• UDI-Public: 07613252656159
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2018

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 Catalogue Number: M003SZAS30210
• Device Lot Number: 19218065
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR