MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40017
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Paralysis (1997); Paresis (1998); Perforation of Vessels (2135); Brain Injury (2219); Loss of consciousness (2418)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the treatment of a micro perforation at m2 of left mca, physician used the microcatheter and guidewires to deploy the subject flow diverting stent.He re -sheathed the subject stent and during deployment it was slightly migrated to forward direction while applying forward pressure to delivery system and covered the mca branch.15 minutes post deployment physician noticed contrast leaking distal to the subject stent indicating vessel perforation.On review of imaging, it was cleared that the perforation happened before subject stent deployment and after the placement of microcatheter and guidewires.It is undeterminable if the devices caused the perforation.Balloon angioplasty was performed to stop bleeding and protamine was administered to reverse heparin.4 hours post procedure patient started bleeding again at m1/m2 bifurcation.Another surgery was performed to remove the blood from brain and the subject stent was seen protruding from the vessel.It is undeterminable if the subject stent caused the perforation.Patient suffered paralysis and is currently in icu.No additional information available.
Additional Manufacturer Narrative
One of the four mdrs.The device is not available to the manufacturer.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned; therefore, physical as well as 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.It was reported that during the procedure the device was resheathed then redeployed.During the second deployment device jumped forward and covered the mca branch.Finished deployment of stent and finished case.15 min post deployment of evolve noticed contrast leaking into brain, indicating perforation of vessel.On review of imaging from case perforation occurred before evolve, and originated from prior to placement of implant."med management and balloon angioplasty were administered to stop bleeding".The perforation occurred after the placement of xt27 and synchro and before the subject stent.Follow up with physician regarding patient the doctor stated patient re-bled around 4 hours post op.Patient moved to neurosurgery to remove blood from brain.During neurosurgery the doctor indicated evolve stent was protruding proximally at the m1/m2 bifurcation.Dr.Patel thinks this could be from the surgeon manipulating the open brain, but ultimately, indeterminate.Protamine administered to reverse heparin, balloon angioplasty done to help stop bleeding/patch vessel.Physician says best outcome is hemiparesis, vegetative state an assignable cause of 'caused by other' will be assigned to the reported 'patient vessel perforation', 'patient intercranial hemorrhage' and 'patient neurological deficit' as additional information states the perforation occurred after the placement of xt27 and synchro and before the subject stent.The investigation indicates another product caused the issue event, leading to 'patient intercranial hemorrhage', ' patient neurological deficit' and 'patient vessel perforation'.It is possible that the stent migrated due to the surgeon manipulating the open brain but this cannot be confirmed.An assignable cause of undeterminable will be assigned to nv - stent dislodged/migrated as review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.
Event or Problem Description
It was reported that during the treatment of a micro perforation at m2 of left mca, physician used the microcatheter and guidewires to deploy the subject flow diverting stent.He re -sheathed the subject stent and during deployment it was slightly migrated to forward direction while applying forward pressure to delivery system and covered the mca branch.15 minutes post deployment physician noticed contrast leaking distal to the subject stent indicating vessel perforation.On review of imaging, it was cleared that the perforation happened before subject stent deployment and after the placement of microcatheter and guidewires.It is undeterminable if the devices caused the perforation.Balloon angioplasty was performed to stop bleeding and protamine was administered to reverse heparin.4 hours post procedure patient started bleeding again at m1/m2 bifurcation.Another surgery was performed to remove the blood from brain and the subject stent was seen protruding from the vessel.It is undeterminable if the subject stent caused the perforation.Patient suffered paralysis and is currently in icu.No additional information available.
Event or Problem Description
It was reported that during the treatment of a micro perforation at m2 of left mca, physician used the microcatheter and guidewires to deploy the subject flow diverting stent.He re -sheathed the subject stent and during deployment it was slightly migrated to forward direction while applying forward pressure to delivery system and covered the mca branch.15 minutes post deployment physician noticed contrast leaking distal to the subject stent indicating vessel perforation.On review of imaging, it was cleared that the perforation happened before subject stent deployment and after the placement of microcatheter and guidewires.It is undeterminable if the devices caused the perforation.Balloon angioplasty was performed to stop bleeding and protamine was administered to reverse heparin.4 hours post procedure patient started bleeding again at m1/m2 bifurcation.Another surgery was performed to remove the blood from brain and the subject stent was seen protruding from the vessel.It is undeterminable if the subject stent caused the perforation.Patient suffered paralysis and is currently in icu.No additional information available.Update: it was reviewed on 04-apr-2022 that the subject flow diverter jumped forward during second deployment attempt and covered mca branch.4 hours post procedure patient started bleeding again for which the patient was moved to neurosurgery to remove blood from brain.During this surgery physician indicated evolve stent was protruding from vessel.The stent was protruding more proximal at the m1/m2 bifurcation.The physician thinks this could be from the surgeon manipulating the open brain, but ultimately, indeterminate.Patient was still in icu last heard.Physician says the best outcome for patient is hemiparesis, vegetative state.
Additional Manufacturer Narrative
B2: outcomes attributed to ae: added: hospitalization-initial or prolonged and disability or permanent, b5 - executive summary: updated.F10: clinical /health signs code grid : paralysis: corrected to paresis; loss of consciousness ¿ added.F10: health impact code grid : intensive care ¿ added.

• Brand Name: SURPASS EVOLVE 4.0MM X 17MM - 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: 13310701
• Report Number: 3008881809-2022-00027
• Device Sequence Number: 5028238
• Product Code: OUT
• UDI-Device Identifier: 07613327386530
• UDI-Public: 07613327386530
• 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): 05/19/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: FDS40017
• Device Catalogue Number: FDS40017
• Device Lot Number: 22451788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 03/31/2022; 05/04/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 04/27/2022; 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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: AXS INFINITY LONG SHEATH (STRYKER); AXS VECTA INTERMEDIATE CATHETER (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER); EXCELSIOR XT27 MICROCATHETER (STRYKER); SELECT CATHETER (PENUMBRA); SYNCHRO 10 GUIDEWIRE (STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER); TRANSFORM BALLOON CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization; Disability
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White