MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 30MM - PMA; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	M003SFD040300
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Codes	Aneurysm (1708); High Blood Pressure/ Hypertension (1908); Rupture (2208)
Date of Event	05/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device remained inside patient.
Event or Problem Description
It was reported that during procedure the subject device (stent) was deployed prematurely in the wrong location.The subject device stent was fully deployed from middle cerebral artery (mca) to cavernous internal carotid artery (ica) and controlled bleeding to an extent but landed further distal than anticipated.The physician tried to drag the subject stent proximal into the ica and the patient¿s blood pressure spiked up which caused an aneurysm rupture near distal segment of supraclinoid ica.The subject device was unable to be removed once fully deployed so left in place and decided not to coil.The patient was administered with the medication in response to the aneurysm rupture.Patient had an evd (external ventricular drain) placed immediately after the procedure.Patient¿s current status is sick but stable.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.As per the available information, the device deployed prematurely in the wrong location, too far distal.The physician tried to drag the stent back and the patient's blood pressure spiked and caused an aneurysm rupture.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the stent premature deployment, and it cannot be definitively determined if the stent premature deployment caused or contributed to the aneurysm rupture and patient complications, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during procedure the subject device (stent) was deployed prematurely in the wrong location.The subject device stent was fully deployed from middle cerebral artery (mca) to cavernous internal carotid artery (ica) and controlled bleeding to an extent but landed further distal than anticipated.The physician tried to drag the subject stent proximal into the ica and the patient¿s blood pressure spiked up which caused an aneurysm rupture near distal segment of supraclinoid ica.The subject device was unable to be removed once fully deployed so left in place and decided not to coil.The patient was administered with the medication in response to the aneurysm rupture.Patient had an evd (external ventricular drain) placed immediately after the procedure.Patient¿s current status is sick but stable.

• Brand Name: SURPASS STREAMLINE 4.0MM X 30MM - 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: 10065501
• Report Number: 3008881809-2020-00150
• Device Sequence Number: 2629002
• Product Code: OUT
• UDI-Device Identifier: 07613252648796
• UDI-Public: 07613252648796
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2020
• Device Model Number: M003SFD040300
• Device Catalogue Number: M003SFD040300
• Device Lot Number: 21785957
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 08/11/2020
• 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: 45 YR