MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STENT DELIVERY SYSTEM 3MMX25MM; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	M003SFD030250
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during procedure for stenting an aneurysm located in the left internal carotid artery (ica) in the petrous segment, the stent (subject device) became locked into the outer delivery catheter and partially deployed.Thus, the forward pressure stretched the distal part of the delivery catheter.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.As per the additional information, the device was confirmed to be in good condition after unpacking and preparation, the patient¿s anatomy was severely tortuous.It is probable that the delivery catheter was damaged during the clinical procedure due to the severe tortuosity causing the difficulty to deploy the stent and the partial stent deployment.Therefore, an assignable cause of procedural factors will be assigned to this investigation.
Event or Problem Description
It was reported that during procedure for stenting an aneurysm located in the left internal carotid artery (ica) in the petrous segment, the stent (subject device) became locked into the outer delivery catheter and partially deployed.Thus, the forward pressure stretched the distal part of the delivery catheter.There were no clinical consequences to the patient.

• Brand Name: SURPASS STENT DELIVERY SYSTEM 3MMX25MM
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8303080
• Report Number: 3008881809-2019-00038
• Device Sequence Number: 18843876
• Product Code: OUT
• UDI-Device Identifier: 07613252648765
• UDI-Public: 07613252648765
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/25/2019

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: 10/08/2019
• Device Catalogue Number: M003SFD030250
• Device Lot Number: 20934483
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR