MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS INFINITY LS 90CM - US; CATHETER, PERCUTANEOUS

Model Number	GEN-10800-90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thromboembolism (2654); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/20/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Subject device not available.
Event or Problem Description
It was reported that during a flow diverter implant procedure, the physician advanced the long sheath catheter (subject device) into the internal carotid artery (ica) - petrous segment and noticed a small clot/thrombus in a middle cerebral artery (m2) branch.Attempts were made to remove the clot with a stent retriever (non-stryker device) but only little portion of the clot was removed.It was decided to proceed with the flow diverter implantation in the ica.Patient died post-procedure.During pathology examination of the clot, it was found a fragment of embedded refractive, non-polarizing foreign material.It is not known if the foreign body was from the subject device or the non-stryker stent retriever.
Event or Problem Description
It was reported that during a flow diverter implant procedure, the physician advanced the long sheath catheter (subject device) into the internal carotid artery (ica) - petrous segment and noticed a small clot/thrombus in a middle cerebral artery (m2) branch.Attempts were made to remove the clot with a stent retriever (non-stryker device) but only little portion of the clot was removed.It was decided to proceed with the flow diverter implantation in the ica.Patient died post-procedure.During pathology examination of the clot, it was found a fragment of embedded refractive, non-polarizing foreign material.It is not known if the foreign body was from the subject device or the non-stryker stent retriever.
Additional Manufacturer Narrative
Although the dhr could not be reviewed because the lot number remains unknown, 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 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.The device was not returned.After 5 attempts and only a little piece removed they decided to proceed with the surpass.It was not identified until after the patient died that the clot that was removed was sent to pathology.It remains unknown what the fragment found in the clot was.If additional information is received at a later date to indicate what material was left in the clot in the anatomy of the patient the investigation will be re-opened to reflect this.According to the physician, no difficulties were encountered during the case using the infinity long sheath.An assignable cause of undeterminable, will be assigned to the reported events, as the device was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.

• Brand Name: AXS INFINITY LS 90CM - US
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9826306
• Report Number: 3008881809-2020-00064
• Device Sequence Number: 14220235
• Product Code: DQY
• UDI-Device Identifier: 07613327298260
• UDI-Public: 07613327298260
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K152876
• 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): 06/08/2020

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: GEN-10800-90
• Device Catalogue Number: GEN-10800-90
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SOLITAIRE STENT (MEDRONIC)
• Outcome Attributed to Adverse Event: Death; Other; Required Intervention