MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 5.0MM X 40MM - PMA; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	M003SFD050400
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
Device is not available to manufacturer.
Event or Problem Description
It was reported 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.
Event or Problem Description
It was reported 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.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated manufacturing execution system (mes), 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 inspection, the stabilizer distal taper tip & radio opaque (ro) marker were detached.The stabilizer proximal marker was intact.The delivery catheter ro marker was detached, the ro marker band was not returned.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 he distal ro marker of the delivery catheter was detached and not returned.The distal tip of the stabilizer (taper tip and ro marker) was also detached and not returned.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 interaction with another device reported, the analyzed ro marker(s) detached/separate/not visible under fluoroscopy and to the analyzed stent stabilizer broken/fractured during use, 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.

• Brand Name: SURPASS STREAMLINE 5.0MM X 40MM - 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: 10939859
• Report Number: 3008881809-2020-00378
• Device Sequence Number: 16952673
• Product Code: OUT
• UDI-Device Identifier: 07613252648864
• UDI-Public: 07613252648864
• 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,Followup
• Report Date (Section B): 02/12/2021

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: 04/02/2021
• Device Model Number: M003SFD050400
• Device Catalogue Number: M003SFD050400
• Device Lot Number: 22178024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AXS OFFSET CATALYST 5 CATHETER (STRYKER); AXS OFFSET CATALYST 5 CATHETER (STRYKER)