MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 20MM - PMA; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	M003SFD040200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Thrombus (2101)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the 14th of 14 reports.Subject device remains implanted.
Event or Problem Description
It was published in a literature abstract that cases performed between 10-jan-2019 to 02-jan-2020 on a total of 55 patients with 68 treated aneurysms were treated with flow diverter (subject device).There were procedure related complications reported in 12 patients.One patient was treated with implant of a flow diverter (subject device) for unruptured aneurysm 8 x 5 mm (aneurysm size 5-9.9 mm) on the right posterior communicating artery recurrently stented with non-stryker coils and non-stryker stent.There was minor complication of left facial droop and left wrist weakness immediately post procedure.There was no definitive stent-associated thrombus causing neurological symptoms on repeat angiography.The patient was treated with intraarterial intracatheter intracerebral integrillin 1 mg and tissue plasminogen activator (tpa) 2 mg in event microembolism would be present.Persistent facial numbness following repeat angiogram/thrombolysis.1 month later, persistent filling of aneurysm measuring 12 x 7 mm on aagnetic resonance angiography (mra).
Additional Manufacturer Narrative
D4: expiration date: updated.H4: manufacturing date: updated.Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device 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 subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.As per the surpass streamline dfu, intented use/indications for use: the surpass streamline flow diverter is indicated for use in the endovascular treatment of patients (18 years of age and older) with unruptured large or giant saccular wide-neck (neck width = 4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter = 2.5 mm and = 5.3 mm.The available information indicates that the patient was treated with implant of a flow diverter (subject device) for unruptured aneurysm 8 x 5 mm (aneurysm size 5-9.9 mm) on the right posterior communicating artery recurrently stented with non-stryker coils and non-stryker stent.Based upon medical review assessment, the data reasonably suggest the clinical event is anticipated in nature and severity as per the dfu/risk documents.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, an assignable cause of anticipated procedural complication will be assigned to this complaint.
Event or Problem Description
It was published in a literature abstract that cases performed between 10-jan-2019 to 02-jan-2020 on a total of 55 patients with 68 treated aneurysms were treated with flow diverter (subject device).There were procedure related complications reported in 12 patients.One patient was treated with implant of a flow diverter (subject device) for unruptured aneurysm 8 x 5 mm (aneurysm size 5-9.9 mm) on the right posterior communicating artery recurrently stented with non-stryker coils andnon-stryker stent.There was minor complication of left facial droop and left wrist weakness immediately post procedure.There was no definitive stent-associated thrombus causing neurological symptoms on repeat angiography.The patient was treated with intraarterial intracatheter intracerebral integrillin 1 mg and tissue plasminogen activator (tpa) 2 mg in event microembolism would be present.Persistent facial numbness following repeat angiogram/thrombolysis.1 month later, persistent filling of aneurysm measuring 12 x 7 mm on aagnetic resonance angiography (mra).

• Brand Name: SURPASS STREAMLINE 4.0MM X 20MM - PMA
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10103968
• Report Number: 3008881809-2020-00163
• Device Sequence Number: 2101186
• Product Code: OUT
• UDI-Device Identifier: 07613252648734
• UDI-Public: 07613252648734
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2020

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: 06/23/2020
• Device Model Number: M003SFD040200
• Device Catalogue Number: M003SFD040200
• Device Lot Number: 21551508
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 05/31/2020
• Supplement Report FDA Received Date: 07/20/2020
• 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; Required Intervention
• Patient Age: 72 YR