MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD40015

Device Problem Activation Failure (3270)

Patient Problems Aneurysm (1708); Paralysis (1997); Movement Disorder (4412); Thrombosis/Thrombus (4440)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

Device is implanted in patient.

Event Description

It was reported that a procedure was performed to treat a recanalized aneurysm in the ophthalmic segment of the internal carotid that had been previously treated with coils months ago.The goal was to implant a flow shunt so that the aneurysm closed completely.It was reported that during the procedure, everything went perfectly, the navigation of the subject flow diverter, its release, as well as the final result, which was excellent (wide open in the vessel covering the neck of the aneurysm).One hour post procedure, the patient woke up with a hemiplegia and immediately underwent a ct scan.The patient was taken to the interventional neuroradiology room where a 3d arteriography was performed.It was seen that the subject flow diverter was occluded proximally, forming "one fish mouth / cone-shaped", and was thrombosed.The physicians decided to inject fibrinolytic to dissolve the thrombus, which was successful, as well as for the proximal part of the implant to recover its usual morphology, allowing them to introduce a microguide and microcatheter to later implant a neuroform atlas intracranial stent which, by its radial force, kept the subject flow diverter open and permeable in the area where it had been occluded.The patient woke up with a problem in her arm, but the symptoms improved considerably compared to the previous hours.No other information is currently available.

Event Description

It was reported that a procedure was performed to treat a recanalized aneurysm in the ophthalmic segment of the internal carotid that had been previously treated with coils months ago.The goal was to implant a flow shunt so that the aneurysm closed completely.It was reported that during the procedure, everything went perfectly, the navigation of the subject flow diverter, its release, as well as the final result, which was excellent (wide open in the vessel covering the neck of the aneurysm).One hour post procedure, the patient woke up with a hemiplegia and immediately underwent a ct scan.The patient was taken to the interventional neuroradiology room where a 3d arteriography was performed.It was seen that the subject flow diverter was occluded proximally, forming "one fish mouth / cone-shaped", and was thrombosed.The physicians decided to inject fibrinolytic to dissolve the thrombus, which was successful, as well as for the proximal part of the implant to recover its usual morphology, allowing them to introduce a microguide and microcatheter to later implant a neuroform atlas intracranial stent which, by its radial force, kept the subject flow diverter open and permeable in the area where it had been occluded.The patient woke up with a problem in her arm, but the symptoms improved considerably compared to the previous hours.No other information is currently available.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.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 provided by the customer indicated that the device was confirmed to be in good condition prior to use, preparation/set-up was performed as per the dfu, continuous flush was maintained for the duration of the procedure, no damage was noted to the stent or stent delivery wire, no excessive force was applied at any point while advancing the stent/flow diverter within the microcatheter, the tortuosity of the anatomy was mild, the stent delivery microcatheter was retracted in a continuous movement while maintaining the position of the stent delivery wire, the size of the flow diverter was appropriate for the treatment site, no resistance was encountered during the procedure, the flow diverter was recaptured/re-sheathed back once during the procedure, and the patient received dual anti-platelet agents both prior to and post procedure.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.

• Brand Name: SURPASS EVOLVE 4.0MM X 15MM - CE
• Type of Device: 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: 12580382
• MDR Text Key: 274939352
• Report Number: 3008881809-2021-00417
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P170024/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2022
• Device Catalogue Number: FD40015
• Device Lot Number: 21805678R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female