MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 5.0MM X 50MM - PMA; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	M003SFD050500
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional 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 lot number was confirmed from the returned packaging and the hub.On visual/microscopic inspection, the distal end of the stabilizer was kinked, the radio opaque (ro) markers were intact.The distal tip of the delivery catheter was stretched and deformed with the ro marker detached, the ro marker band was still contained on the stabilizer.Functional testing was not performed due to the damage noted to the device, and as the defect was visually confirmed.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 available information states that there was a marker band found detached within the axs catalyst 5 catheter, it could not be determined which device it was from.The device was returned and it was confirmed that the distal end of the stabilizer was kinked, the radio opaque (ro) markers were present.The distal tip of the delivery catheter was stretched and deformed with the ro marker detached, the ro marker band was still contained on the stabilizer.It is probable that the device was damaged during the clinical procedure.An assignable cause of procedural factors will be assigned to the reported device problem unknown/unclear and analyzed ro marker(s) detached/separate/not visible under fluoroscopy, stent stabilizer kinked/bent, stent delivery catheter stretched and stent delivery catheter 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.
Event or Problem Description
Analysis of the returned device revealed that the subject flow diverter's radio opaque marker detached inside the catheter during procedure.No clinical consequences were reported to the patient due to this event.

• Brand Name: SURPASS STREAMLINE 5.0MM X 50MM - PMA
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11355813
• Report Number: 3008881809-2021-00088
• Device Sequence Number: 17155033
• Product Code: OUT
• UDI-Device Identifier: 07613252648840
• UDI-Public: 07613252648840
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Report Date (Section B): 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2021
• Device Model Number: M003SFD050500
• Device Catalogue Number: M003SFD050500
• Device Lot Number: 22098131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1