MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 20MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Intracranial Hemorrhage (1891); Perforation of Vessels (2135)
Date of Event	09/20/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that post successful deployment of the stent (subject device) significant contrast extravasation was visualized due to vessel perforation from the lead wire of the stent (subject device) at the left m1/m2 bifurcation.Evd placed due to significant amount of blood, protomine was given by anesthesia to reverse the heparin that was given during procedure as a medical intervention.This did not stop the bleeding, so physician placed a balloon as a medical intervention in the m1 segment to stop and prevent future extravasation of blood into the brain, and subsequently decided to coil sacrifice the entire m1 segment.Patient is not responding to stimuli.Patient received a ventriculostomy in the procedure room immediately after the surgery.Patient also required hemicraniectomy for brain swelling a few days after procedure.Patient passed away.The relationship of patient death to the subject device and the associated procedure is unknown.
Event or Problem Description
It was reported that post successful deployment of the stent (subject device) significant contrast extravasation was visualized due to vessel perforation from the lead wire of the stent (subject device) at the left m1/m2 bifurcation.Evd placed due to significant amount of blood, protomine was given by anesthesia to reverse the heparin that was given during procedure as a medical intervention.This did not stop the bleeding, so physician placed a balloon as a medical intervention in the m1 segment to stop and prevent future extravasation of blood into the brain, and subsequently decided to coil sacrifice the entire m1 segment.Patient is not responding to stimuli.Patient received a ventriculostomy in the procedure room immediately after the surgery.Patient also required hemicraniectomy for brain swelling a few days after procedure.Patient passed away.The relationship of patient death to the subject device and the associated procedure is unknown.Update information: received additional information on 19-oct-2022 confirmed.Cause of death is related to brain death due to sah and brain swelling.It is indeterminate if vessel perforation was caused by the stent (subject device), catheter or guidewire lead wire.
Additional Manufacturer Narrative
This is 1/3 emdr (1st emdr report).B5 executive summary - updated c2/d10 concomitant products grid - added.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) 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.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.Post successful deployment of the subject stent in the left ica (internal carotid artery) a vessel perforation occurred, and it was undeterminable if the vessel perforation was caused by guidewire, microcatheter or subject stent lead wire.Coil sacrifice of the left mca (middle cerebral artery) to stop hemorrhage, evd placed due to significant amount of blood.Protomine was given by anesthesia to reverse the heparin that was given during procedure.Physician placed a balloon in the m1 segment to tamponade the vessel.Patient received a ventriculostomy in the procedure room immediately after the surgery.Patient also required hemicraniectomy for brain swelling a few days after procedure.The patient died as an outcome of the adverse event.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to the reported 'patient vessel perforation', 'patient intracranial hemorrhage' and 'patient death'.
Event or Problem Description
It was reported that post successful deployment of the stent (subject device) significant contrast extravasation was visualized due to vessel perforation from the lead wire of the stent (subject device) at the left m1/m2 bifurcation.Evd placed due to significant amount of blood, protomine was given by anesthesia to reverse the heparin that was given during procedure as a medical intervention.This did not stop the bleeding, so physician placed a balloon as a medical intervention in the m1 segment to stop and prevent future extravasation of blood into the brain, and subsequently decided to coil sacrifice the entire m1 segment.Patient is not responding to stimuli.Patient received a ventriculostomy in the procedure room immediately after the surgery.Patient also required hemicraniectomy for brain swelling a few days after procedure.Patient passed away.The relationship of patient death to the subject device and the associated procedure is unknown.Update information: received additional information on 19-oct-2022 confirmed.Cause of death is related to brain death due to sah and brain swelling.It is indeterminate if vessel perforation was caused by the stent (subject device), catheter or guidewire lead wire.

• Brand Name: SURPASS EVOLVE 4.5MM X 20MM - PMAS
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• 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: 15629568
• Report Number: 3008881809-2022-00512
• Device Sequence Number: 5911805
• Product Code: OUT
• UDI-Device Identifier: 07613327375251
• UDI-Public: 07613327375251
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• 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,Followup
• Report Date (Section B): 12/09/2022

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 Expiration Date: 10/11/2024
• Device Model Number: FDS45020
• Device Catalogue Number: FDS45020
• Device Lot Number: 23249158
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 11/18/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/01/2022; 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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: SYNCHRO 2 GUIDEWIRE (STRYKER); XT-27 CATHETER (STRYKER); XT-27 CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Hospitalization; Death; Other; Required Intervention
• Patient Sex: Unknown