MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 12MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD32512

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the surpass evolve flow diverter was partially deployed from the distal tip of the microcatheter and the stent was not seated on the resheath pad.The stent was also slightly deformed at the distal end as frayed wires were present.During functional testing, the stent was not seated on the resheath pad; therefore, it was not possible to resheath the stent.The stent delivery wire (sdw) was advanced and the remainder of the stent was deployed without any issue.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 regarding the device indicated that there was no damage noted to the packaging or system, it was confirmed that the implant and delivery wire were properly pre-loaded in the distal tip of the introducer sheath, the device was prepared as per the dfu, continuous flush was maintained throughout the procedure and the patient¿s anatomy was not tortuous.There was no resistance encountered when transferring the implant from the introducer sheath into the microcatheter.The only resistance encountered was when the physician was trying to resheath the stent, the physician felt tension and it was difficult to resheath.The stent did not fully expand and was re-captured.The device was returned and the stent was not seated on the resheath pad and there was some deformation noted to the distal end of the stent which most likely occurred as a result of excessive handling of the device during advancement/resheathing.The dislodgement of the stent from the resheath pad would have contributed to the stent failing to open up fully when unsheathed and also result in difficulties resheathing the stent.An assignable cause of procedural factors was assigned to the reported and analysed issue stent failed/unable to open (when not implanted)¿ and to the analysed issues stent partial deployment, stent difficult/unable to pull back into sheath 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.This is 3rd of 3 reports.

Event Description

Analysis of the returned device found that the stent was partially deployed.There were no clinical consequences to the patient reported as a result of this event.

Event Description

Analysis of the returned device found that the stent was partially deployed.There were no clinical consequences to the patient reported as a result of this event.Additional information received on 16-nov-2021 indicated that the physician placed a microcatheter in the right middle cerebral artery (mca) and tried to deploy the first flow diverter stent; however, the distal end of the flow diverting stent would not open in the internal carotid artery.When trying to remove from the patient¿s anatomy, the physician encountered resistance when re-sheathing the flow diverter.The physician retrieved the partially deployed stent with the microcatheter together from the patient¿s anatomy.A second attempt was made with the second subject flow diverter stent, but the distal end of the stent once again would not open fully.Similar resistance was encountered when re-sheathing the subject stent.Once again, the physician was able to retrieve the stent to partial re-sheathing with the microcatheter.Once retrieved, the microcatheter appeared to be crimped.

Manufacturer Narrative

A1: patient identifier - updated.B5: executive summary - updated.B7: other relevant history - updated.H10 and/or h11: additional mfg narrative - updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the surpass evolve flow diverter was partially deployed from the distal tip of the microcatheter and the stent was not seated on the re-sheath pad.The stent was also slightly deformed at the distal end as frayed wires were present.During functional testing, the stent was not seated on the re-sheath pad; therefore, it was not possible to re-sheath the stent.The stent delivery wire (sdw) was advanced and the remainder of the stent was deployed without any issue.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 regarding the device indicated that there was no damage noted to the packaging or system, it was confirmed the implant and delivery wire were properly pre-loaded in the distal tip of the introducer sheath, the device was prepared as per the dfu, continuous flush was maintained throughout the procedure and the patient¿s anatomy was not tortuous.There was no resistance encountered when transferring the implant from the introducer sheath into the microcatheter.The only resistance encountered was when the physician was trying to re-sheath the stent, the physician felt tension and it was difficult to re-sheath.The stent did not fully expand and was re-captured.Additional information received on 16-nov-2021 indicated that the physician encountered resistance when re-sheathing the subject flow diverter.The physician retrieved the partially re-sheathed stent with the microcatheter together from the patient¿s anatomy.The device was returned, and the stent was not seated on the re-sheath pad and there was some deformation noted to the distal end of the stent which most likely occurred as a result of excessive handling of the device during advancement/re-sheathing.The dislodgement of the stent from the re-sheath pad would have contributed to the stent failing to open up fully when unsheathed and also result in difficulties re-sheathing the stent.An assignable cause of procedural factors was assigned to the reported issues stent failed/ unable to open (when not implanted), stent partial deployment, and stent difficult/unable to pull stent back into sheath, also to the analyzed issues stent partial deployment, stent difficult/unable to pull back into sheath, and stent deformed as the issue are 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.

• Brand Name: SURPASS EVOLVE 3.25MM X 12MM - 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: 10798137
• MDR Text Key: 215286601
• Report Number: 3008881809-2020-00338
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2021
• Device Catalogue Number: FD32512
• Device Lot Number: 22194408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2020
• 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
• Treatment: 2 SURPASS EVOLVE (STRYKER); 2 XT-27 MICROCATHETER (STRYKER); AXS CATALYST 5 CATHETER (STRYKER)
• Patient Age: 57 YR
• Patient Sex: Female