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	Premature Activation (1484)
Health Effect - Clinical Codes	Stenosis (2263); Vascular Dissection (3160)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the paraopthalmic aneurysm procedure, the physician was unable to fully open the subject flow diverting stent at the target lesion.It was resheathed and after the 3rd resheathing attempt, the subject flow diverting stent deployed prematurely within the microcatheter.During manipulation to properly deploy the subject flow diverting stent the left internal carotid artery (ica) got dissected and the procedure was aborted.The subject flow diverting stent was removed with the microcatheter.Patient was given heparin, asprin (asa) and billinta and also discharged on (b)(6) 2022.Imaging was performed which showed dissection but patent flow with areas of stenosis.The collateral flow was started due to which the flow wasn't shut completely.The patient was stable.No additional information available.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the device was returned inserted in the microcatheter.The stent was found to be partially deployed.The device was flushed and the sdw advanced through the microcatheter without any issues.The stent was fully deployed without issue and was noted to be slightly deformed.The sdw was noted to be kinked from the proximal end of the device.The stent introducer sheath was not returned.During functional inspection, stent failed/unable to open (when not implanted) was not confirmed during advancement and the stent was noted to be slightly deformed, but the analyzed defects are consistent with the reported event.Stent deployed prematurely during use was confirmed as the device was returned partially deployed in the microcatheter.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.Additional information indicates the following: para-ophthalmic aneurysm was being treated and a rather tortuous ica.The stent would not fully open and after a 3rd resheathing, the stent implant fell off the resheathing pad and could not be deployed and needed to be removed.There was much manipulation during this case and a vessel dissection occurred.The stent was removed, and the case was aborted.There was no medical intervention to treat the dissected vessel.The patient is now clinically intact and being discharged home today with asa and brillinta.Follow up cth showed no infarct or hemorrhage, cta showed the left ica dissections but patent flow with areas of stenosis.Thankfully, her collaterals arrived robust, and the dissections did not shut the flow down entirely.Additional information states the anatomy was very tortuous, the device was prepped as per dfu, and the physician believes the vessel was dissected during the resheathing and migration of the long sheath as manipulations were being made to try and improve the proximal support to help the stent open better.It is most likely that due to the severe tortuosity vessel, the physician experienced difficulty when deploying the stent, which led to 3 attempts in resheathing the stent in order to deploy the stent correctly.During these attempts the vessel was unintentionally dissected, and the subsequent reported stenosis.An assignable cause of procedural factors will be assigned to the as reported defects ¿stent failed/unable to open (when not implanted), ¿stent prematurely deployed during use¿, ¿patient vessel dissection¿ and ¿non-flow limiting vessel stenosis' and to the as analyzed defects ¿stent partial deployment¿, ¿stent deployed prematurely during use¿, ¿sdw kinked/bent¿ and ¿stent deformed¿ as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during the paraopthalmic aneurysm procedure, the physician was unable to fully open the subject flow diverting stent at the target lesion.It was resheathed and after the 3rd resheathing attempt, the subject flow diverting stent deployed prematurely within the microcatheter.During manipulation to properly deploy the subject flow diverting stent the left internal carotid artery (ica) got dissected and the procedure was aborted.The subject flow diverting stent was removed with the microcatheter.Patient was given heparin, asprin (asa) and billinta and also discharged on (b)(6) 2022.Imaging was performed which showed dissection but patent flow with areas of stenosis.The collateral flow was started due to which the flow wasn't shut completely.The patient was stable.No additional information available.

• 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: 15957493
• Report Number: 3008881809-2022-00615
• Device Sequence Number: 5549565
• Product Code: OUT
• UDI-Device Identifier: 07613327386530
• UDI-Public: 07613327386530
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 01/24/2023

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: 08/06/2023
• Device Model Number: FDS40017
• Device Catalogue Number: FDS40017
• Device Lot Number: 22387949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2020
• 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: EXCELSIOR XT 27 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female