MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STENT DELIVERY SYSTEM 4MMX20MM; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	M003SFD040200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Facial Nerve Paralysis (1846)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the proximal end of the subject stent was found damaged and the patient experienced stoke post stenting procedure.Medical intervention was performed to treat the patient.No other information was provided.
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the stent delivery catheter was returned with the stent stabilizer.The stabilizer/pusher wire and distal delivery catheter were noted to be kinked/bent.Dimensional and functional testing could not be performed since the actual sent was not returned for evaluation.The reported event is covered in the device direction 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 additional information provided by the customer indicated that there was no damage noted to the device prior to use and the device was prepared as per dfu.It is probable that the procedural or anatomical factors present during the clinical procedure resulted in difficulty deploying the stent leading to the reported event and the observed damages ( stent delivery catheter and stabilizer kink).An assignable cause of anticipated procedural complication was assigned to the as reported issues patient stroke and patient complications (facial droop), as a device related root cause does not apply and the issue is due to a known physiological effect that is noted with the direction for use, device labeling and/or risk documentation.
Event or Problem Description
It was reported that during the procedure, the proximal end of the subject stent was found damaged and the patient experienced stoke post stenting procedure.Medical intervention was performed to treat the patient.No other information was provided.Additional information was received on october 09, 2019 indicating that the patient is currently experiencing facial droop due to the stroke.

• Brand Name: SURPASS STENT DELIVERY SYSTEM 4MMX20MM
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9089432
• Report Number: 3008881809-2019-00281
• Device Sequence Number: 19407751
• Product Code: OUT
• UDI-Device Identifier: 07613252648734
• UDI-Public: 07613252648734
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2020
• Device Catalogue Number: M003SFD040200
• Device Lot Number: 21243865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention