MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40012
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a flow diverter stent implantation procedure in a patient with internal carotid artery aneurysm, when the physician attempted to recapture the subject flow diverter stent the microcatheter would not advance over the subject stent the physician removed the subject stent and the microcatheter into the intermediate catheter and then removed from the patient vasculature.The procedure was completed successfully by replacing the device.There was a surgical delay of 5-10 min due to the device malfunction.No other clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
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 device was returned and the lot number was confirmed with the packaging.During visual/microscopic inspection, the stent delivery wire (sdw) was returned inserted in the microcatheter.The introducer sheath and stent were not returned.The microcatheter was found to be intact.The sdw was found to be kinked in several locations throughout the device.Functional inspection was unable to be performed as the stent was deployed and not returned with the device.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 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 indicated that the device was confirmed to be in good condition prior to use and preparation/set-up was performed as per the directions for use.Continuous flush was maintained.A.027¿ microcatheter was used with the stent and no allegation was made with the microcatheter.Flow diversion treatment of sidewall on the ica aneurysm ophthalmic was being treated.The anatomy was mildly tortuous.No difficulties were encountered during the procedure.No resistance was encountered during the stent deployment.The stent was attempted to be recaptured once.The stent was removed from the patient.There was 5-10 minute surgical delay.An assignable cause of procedural factors will be assigned to the as reported event of flow diverter stent difficult/unable to recapture into micro-catheter and as analyzed event of stent deployed prematurely during use, 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 a flow diverter stent implantation procedure in a patient with internal carotid artery aneurysm, when the physician attempted to recapture the subject flow diverter stent the microcatheter would not advance over the subject stent the physician removed the subject stent and the microcatheter into the intermediate catheter and then removed from the patient vasculature.The procedure was completed successfully by replacing the device.There was a surgical delay of 5-10 min due to the device malfunction.No other clinical consequences were reported to the patient due to this event.

• Brand Name: SURPASS EVOLVE 4.0MM X 12MM - 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: 14569768
• Report Number: 3008881809-2022-00258
• Device Sequence Number: 20277226
• Product Code: OUT
• UDI-Device Identifier: 07613327386516
• UDI-Public: 07613327386516
• Combination Product (Y/N): N
• 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): 08/24/2022

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: 10/18/2024
• Device Model Number: FDS40012
• Device Catalogue Number: FDS40012
• Device Lot Number: 23265857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• 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: AXS OFFSET CATHETER (STRYKER).; AXS OFFSET CATHETER (STRYKER).; BALLAST 90 LONG SHEATH (BALT).; BALLAST 90 LONG SHEATH (BALT).; XT-27 MICROCATHETER (STRYKER).; XT-27 MICROCATHETER (STRYKER).
• Patient Sex: Unknown