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U.S. Department of Health and Human Services

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

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STRYKER NEUROVASCULAR CORK AXS INFINITY LS 90CM - US CATHETER, PERCUTANEOUS Back to Search Results
Model Number GEN-10800-90
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Thromboembolism (2654); Device Embedded In Tissue or Plaque (3165)
Event Date 02/20/2020
Event Type  Death  
Manufacturer Narrative

Subject device not available.

 
Event 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.

 
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Brand NameAXS INFINITY LS 90CM - US
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key9826306
MDR Text Key183236462
Report Number3008881809-2020-00064
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK152876
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberGEN-10800-90
Device Catalogue NumberGEN-10800-90
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/12/2020 Patient Sequence Number: 1
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