MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 20MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS50020
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure that the subject stent prematurely deployed while attempting to re-sheath.The physician replaced it with a new device and completed the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection the device was returned together with catheter.The stent delivery wire was found to be kinked/bent.The deployed stent was found to be inside returned catheter.The stent was removed using patency mandrel.The stent wire ends were found to be damaged.The introducer sheath was not returned.The returned catheter was intact.Functional testing was not performed.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 event was confirmed during the device analysis.The device failed to meet specification when returned for analysis.It was reported that the stent deployed half was outside the catheter and half was inside.It is probable that the device was damaged during the clinical procedure, causing the reported event.An assignable cause of procedural factors will be assigned to the reported event of the stent deployed prematurely during use and to the analyzed event of the stent delivery wire kinked/bent, the stent deformed and the stent deployed prematurely during use, as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.
Event or Problem Description
It was reported during the procedure that the subject stent prematurely deployed while attempting to re-sheath.The physician replaced it with a new device and completed the procedure without clinical consequences to the patient.

• Brand Name: SURPASS EVOLVE 5.0MM X 20MM - 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: 12457336
• Report Number: 3008881809-2021-00372
• Device Sequence Number: 11753388
• Product Code: OUT
• UDI-Device Identifier: 07613327375299
• UDI-Public: 07613327375299
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/12/2021

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: 01/02/2024
• Device Model Number: FDS50020
• Device Catalogue Number: FDS50020
• Device Lot Number: 22660968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2021
• 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
• Patient Sex: Male