MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 4.5MM X 30MM - HDE; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003N3EZ45300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Headache (1880); Cerebral Edema (4403)
Date of Event	10/21/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted patient.
Event or Problem Description
It was reported that during the procedure on (b)(6) 2015, the patient was treated for a basilar artery aneurysm with the subject stent.The patient suffered a stroke during the procedure and was admitted into intensive care unit (icu).Post procedural imaging was not clear due to much reflection.Patient was then discharged but had disability and severe headache.Patient was re-admitted into the icu and given intravenous steroids for brain swelling.Patient reported to be on pain and migraine medication for the last 6 years due to pressure inside the head.Post-surgical follow ups have been unsuccessful as other physicians report to be unable to find the source of the pain.Patient is not in contact with physician who performed procedure due to conflict.Patient is currently on migraine treatment, blood thinner and antihypertensives.No other information is available.
Additional Manufacturer Narrative
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.Although the lot number was not provided, the automated manufacturing execution system (mes) has 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.Based on review of the event information, it is unclear if clipping was done first.Information is contradictory.Good faith efforts have been exhausted in response to a request for further information and the limited information available does not indicate a need for escalation of the event to senior management.No additional information was received.The dfu states "the stent system is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of = 2 mm and = 4.5 mm that are not amenable to treatment with surgical clipping.Select a stent size (length and diameter) to maintain a minimum of 4 mm on each side of the aneurysm neck along the parent vessel.An incorrectly sized stent may result in damage to the vessel or stent migration.Therefore, the stent is not designed to treat an aneurysm with a neck greater than 22 mm in length." it appears that in this case the clip/removal of wide neck 70mm/7cm basil art aneurysm was approved by the surgeon.This complaint will be assigned user error as there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.H3 other text : device remains implanted patient.
Event or Problem Description
It was reported that during the procedure on (b)(6)2015, the patient was treated for a basilar artery aneurysm with the subject stent.The patient suffered a stroke during the procedure and was admitted into intensive care unit (icu).Post procedural imaging was not clear due to much reflection.Patient was then discharged but had disability and severe headache.Patient was re-admitted into the icu and given intravenous steroids for brain swelling.Patient reported to be on pain and migraine medication for the last 6 years due to pressure inside the head.Post-surgical follow ups have been unsuccessful as other physicians report to be unable to find the source of the pain.Patient is not in contact with physician who performed procedure due to conflict.Patient is currently on migraine treatment, blood thinner and antihypertensives.No other information is available.

• Brand Name: NEUROFORM 3 EZ 4.5MM X 30MM - 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: 12617852
• Report Number: 3008881809-2021-00427
• Device Sequence Number: 11086798
• Product Code: NJE
• UDI-Device Identifier: 04546540697882
• UDI-Public: 04546540697882
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H020002/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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 Model Number: M003N3EZ45300
• Device Catalogue Number: M003N3EZ45300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: COIL MASS (UNKNOWN); STENT (UNKNOWN)
• Outcome Attributed to Adverse Event: Hospitalization; Disability; Required Intervention; Other
• Patient Sex: Unknown