MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 20MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003110FPP0

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

It was reported that the stent (subject device) was used for an aneurysm at the right ica c2.When the physician deployed the stent (subject device) from the side of achoa the distal part of the stent (subject device) did not be deployed well.Pta by scepter xc 4x11 (terumo) was performed for stent crimping.However, the distal part of the stent (subject device) did not be deployed in the end and it seemed that the stent (subject device) edge was bent while it could covered whole the neck of the aneurysm.Imaging was performed (cone-beam ct) and revealed that the stent (subject device) edge was bent at the position about 5mm from the distal end of the stent (subject device).

Manufacturer Narrative

The device is not available to manufacturer.

Manufacturer Narrative

Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that the distal part of the stent did not be deployed well.However, the distal part of the stent did not be deployed in the end and it seemed that the stent edge was bent while the stent could cover whole the neck of the aneurysm.Additional information was not provided after 3 gfe attempts.It is most likely that anatomical factors contributed to the reported event, but this cannot be conclusively determined.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 will be assigned to this complaint.

Event Description

It was reported that the stent (subject device) was used for an aneurysm at the right ica c2.When the physician deployed the stent (subject device) from the side of achoa the distal part of the stent (subject device) did not be deployed well.Pta by scepter xc 4x11 (terumo) was performed for stent crimping.However, the distal part of the stent (subject device) did not be deployed in the end and it seemed that the stent (subject device) edge was bent while it could covered whole the neck of the aneurysm.Imaging was performed (cone-beam ct) and revealed that the stent (subject device) edge was bent at the position about 5mm from the distal end of the stent (subject device).

• Brand Name: SURPASS STREAMLINE 4.0MM X 20MM - 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: 14138782
• MDR Text Key: 289879077
• Report Number: 3008881809-2022-00180
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2023
• Device Catalogue Number: M003110FPP0
• Device Lot Number: 22469417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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: SCEPTER XC 4X11 (TERUMO MANUFACTURER)
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 67 KG