MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 25MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45025
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device remained inside patient.
Event or Problem Description
It was reported that 9 months post flow diverter stent placement procedure for left ica (internal communicating artery) aneurysm, the subject device (stent) was retracted and was no longer in the position.The subject device stent moved distal and proximal tines were not as opened resulting slowed flow through the subject device and to distal vessels.The balloon angioplasty with sceptor and tacked down with atlas stent as medical intervention.The patient was discharged and doing well.
Event or Problem Description
It was reported that 9 months post flow diverter stent placement procedure for left ica (internal communicating artery) aneurysm, the subject device (stent) was retracted and was no longer in the position.The subject device stent moved distal and proximal tines were not as opened resulting slowed flow through the subject device and to distal vessels.The balloon angioplasty with sceptor and tacked down with atlas stent as medical intervention.The patient was discharged and doing well.
Additional Manufacturer Narrative
Although the dhr (device history record) could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to this complaint.

• Brand Name: SURPASS EVOLVE 4.5MM X 25MM - 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: 14599323
• Report Number: 3008881809-2022-00268
• Device Sequence Number: 5901047
• Product Code: OUT
• UDI-Device Identifier: 07613327375268
• UDI-Public: 07613327375268
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FDS45025
• Device Catalogue Number: FDS45025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 06/04/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: SCEPTER BALLOON CATHETER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown