MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS ELITE FDS 4.5MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDSE45015
Medical Device Problem Codes	Malposition of Device (2616); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure the physician noticed some ribboning around the genu and were able to work out the ribbon after awhile which led the physician to feel comfortable to deploy the subject stent.Once deployed, the physician noticed the subject stent did not open much more than it showed around the anterior genu.The subject stent was twisted/torqued.Once the physician was able to get through the twisted part of the subject stent, the physician decided to deploy a retriever and was able to open the device enough to help get a balloon catheter through.The physician then inflated the balloon and the stent finally opened.There was surgical delay of 1.5hrs due to this event.
Event or Problem Description
It was reported that during a procedure the physician noticed some ribboning around the genu and were able to work out the ribbon after awhile which led the physician to feel comfortable to deploy the subject stent.Once deployed, the physician noticed the subject stent did not open much more than it showed around the anterior genu.The subject stent was twisted/torqued.Once the physician was able to get through the twisted part of the subject stent, the physician decided to deploy a retriever and was able to open the device enough to help get a balloon catheter through.The physician then inflated the balloon and the stent finally opened.There was surgical delay of 1.5hrs due to this event.
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.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 ¿in this case everything was going smoothly, patient anatomy was relatively straight forward.We started to notice some ribboning around the genu and were able to work out the ribbon after awhile which led us to feel comfortable to deploy the stent.Once deployed, we noticed the stent did not open much more than it showed around the anterior genu.As we tried to get back through the stent, we could not reaccess and noticed that the device was twisted/torqued.We then had to switch to a microcatheter.Once we were able to get through the twisted part of the device, we then deployed a retriever and she was able to open the device enough to help us get a balloon through, we then inflated the balloon and the stent finally opened.¿ additional information provided by the customer did not indicate any issues noted to the device prior to use and the device was prepared as per dfu instructions.There was no indication of a user related issue.The patient received dual anti-platelet agents prior to the procedure and post procedure.Access was through femoral.The anatomy location/vessel name of intended treatment was paraopthalmic/anterior genu aneurysm of internal carotid artery (ica).There was no resistance encountered during navigation of the flow diverter device to the target lesion.The position of the delivery catheter was confirmed by visualizing the radiopaque markers.The flow diverter was recaptured/resheathed back during the procedure once.There was unnecessary ribboning encountered during the flow diverter deployment.In the physician¿s opinion the cause of the flow diverter not to open was a twist/torsion.There was a surgical delay of 1.5 hours.The medical intervention was that a ¿retriever and balloon used to open the stent¿ that was all.There was no clinical consequence to the patient due to the reported event but could have shut down the distal ica and rest of the distal branches if the twist wasn't fixed.The patient was not affected as a result of the event but could have been really bad if twist wasn't fixed.The procedure was completed successfully by getting a microcatheter distal to the twist, putting in a retriever, and manually opening the stent, after we put in a balloon to open the stent and get rid of the twist.There were no changes noted to the vessel wall at implantation site.The reason between the delay between the event date (02/24/2026) and the date filed was that the procedure end result was good and everything looked great so did not think to report this.After discussing with marketing more and wanting to get dr.Paul involved with a discussion we decided that we should report this.Based on the images, the stent selected was appropriate for the patient¿s vessel and it initially deployed as expected with good apposition until ribboning occurred.It¿s possible there was slack in the system that contributed to the ribboning.The stent may have been compromised during removal of the ribboning, which could have prevented it from fully opening.While there are a number of potential causes for the reported event , because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned for the reported event ¿ stent improperly deployed¿ and ¿stent failed/unable to open¿.

• Brand Name: SURPASS ELITE FDS 4.5MM X 15MM - 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: 24728842
• Report Number: 3008881809-2026-00177
• Device Sequence Number: 21380310
• Product Code: OUT
• UDI-Device Identifier: 07613327582888
• UDI-Public: (01)07613327582888(17)280824(10)25810754
• Combination Product (Y/N): N
• 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): 04/27/2026

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 Catalogue Number: FDSE45015
• Device Lot Number: 25810754
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• 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 SL-10 MICROCATHETER (STRYKER).; TIGERTRIEVER (RAPID MEDICAL).; TRANSFORM OCCLUSION BALLOON CATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Unknown