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	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the internal carotid artery aneurysm procedure, physician tried to deploy the subject flow diverting stent.However, it did not open inside the patient anatomy and was re sheathed once and deployed.The subject flow diverting stent was not fully opened from the proximal end.Physician used a balloon to perform angioplasty and an additional stent was deployed at the proximal end to get a good vessel wall apposition.The procedure was completed successfully.No clinical consequences were reported to the patient 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.During visual/microscopic inspection, the sdw was returned and there was some slight kinking/bending noted to the distal end of the sdw.The petal/drape was in the deployed state.Traces of dried blood were found on the sdw proximal to the resheath pad.The stent was not returned.Functional test was not applicable as the stent 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.The reported complaint was not confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomaly noted to the device.Additional information provided by the customer indicates there were no anomalies noted to the device prior to use, the device was prepared as per dfu, continuous flush was maintained throughout the procedure.The recommended 027 delivery catheter was used, the delivery catheter and pusher were purged with sterile saline and verified that fluid exited the end of the delivery catheter and pusher.The outer diameter of the guidewire used was 014.The position of the delivery catheter was confirmed by visualizing the radiopaque markers and the position of the flow diverter implant was confirmed between the two marker bands.There was no resistance between the delivery catheter and the pusher, there was no resistance encountered during navigation of the flow diverter device to the target lesion and no resistance encountered during the flow diverter deployment.The physician is unsure what was the cause of the reported issue.There was no high % stenosis proximal to the flow diverter likely contributing to the inability to deploy the flow diverter.The physician did not attempt to deploy the flow diverter on the table (outside the patient body) because the device was implanted.There was no resistance during advancement of the flow diverter delivery system through the patient¿s anatomy.The patient¿s anatomy was standard anatomy.The condition being treated was internal carotid artery (ica) aneurysm and the anatomical location of the treatment site was ica.The issue was the proximal end of the flow diverter stent did not open after fully unsheathing from microcatheter.The stent proximal end did not open when the device was released off resheath pad.The device was deployed as per the recommended technique.No aggressive manipulations were used.Device was resheathed 1 time to flip petal (distal 5mm of stent unsheathed and resheathed).The device was implanted into the patient and the proximal end eventually opened with a balloon and pinned with a stent which were not planned to be used in the surgery but were used as medical intervention.The delivery wire is being sent back.Stent is not being sent back as it was implanted into patient.Product analysis found distal end of the sdw was slightly kinked/bent.The petal/drape on the sdw was in the deployed state.Traces of dried blood were found on the sdw proximal to the resheath pad.The stent was not returned.The as reported ¿stent failed/unable to open¿ could not be confirmed during product analysis as the stent was not returned.Based on the additional information received the stent was implanted in the patient.An assignable cause of procedural factors will be assigned to the as reported ¿stent failed/unable to open¿ and as analyzed ¿sdw kinked/bent¿ 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 internal carotid artery aneurysm procedure, physician tried to deploy the subject flow diverting stent.However, it did not open inside the patient anatomy and was re sheathed once and deployed.The subject flow diverting stent was not fully opened from the proximal end.Physician used a balloon to perform angioplasty and an additional stent was deployed at the proximal end to get a good vessel wall apposition.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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: 15795960
• Report Number: 3008881809-2022-00572
• Device Sequence Number: 4754464
• Product Code: OUT
• UDI-Device Identifier: 07613327375251
• UDI-Public: 07613327375251
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/17/2023

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: 03/07/2024
• Device Model Number: FDS45020
• Device Catalogue Number: FDS45020
• Device Lot Number: 22794679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• 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: EXCELSIOR SL 10 MICROCATHETER (STRYKER); EXCELSIOR XT 27 MICROCATHETER (STRYKER); NEUROFORM ATLAS STENT SYSTEM (STRYKER); SCEPTER BALLOON CATHETER (MICROVENTION)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown