MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 21MM NO TIP- HDE; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003SZAS40210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that 2 years 5 months post implantation of the stent (subject device) the patient suffered a transient ischemic attack (tia) at the posterior basilar apex artery on (b)(6) 2020.The tia was resolved with no residual effects on (b)(6) 2020.The physician stated that the tia had a possible relation to the implanted subject device and confirmed that the patient was noncompliant with asa medication regimen.The patient restarted asa medication regimen.No further 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.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.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 event was unable to be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.Additional information received from the customer indicated that the tia was related to the patient noncompliance of medication.An assignable cause of anticipated procedural complication will be assigned to the reported event as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported that 2 years 5 months post implantation of the stent (subject device) the patient suffered a transient ischemic attack (tia) at the posterior basilar apex artery on (b)(6) 2020.The tia was resolved with no residual effects on (b)(6) 2020.The physician stated that the tia had a possible relation to the implanted subject device and confirmed that the patient was noncompliant with asa medication regimen.The patient restarted asa medication regimen.No further information is available.

• Brand Name: NEUROFORM ATLAS 4.0MM X 21MM 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
• MDR Report Key: 11208036
• Report Number: 3008881809-2021-00042
• Device Sequence Number: 19718969
• Product Code: NJE
• UDI-Device Identifier: 07613252656197
• UDI-Public: 07613252656197
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P180031
• 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): 02/09/2021

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: 04/30/2021
• Device Model Number: M003SZAS40210
• Device Catalogue Number: M003SZAS40210
• Device Lot Number: 18996296
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TARGET COIL (STRYKER); TARGET COIL (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR