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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
Catalog Number GEN-10800-90
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 12/17/2020
Event Type  Injury  
Event Description
It was reported that the subject infinity long sheath device was used with other devices to treat the location of proximal face of clot on the right mca (middle cerebral artery) -m1 extending m2.Prior procedure, the patient neurological assessment showed the tici (thrombolysis in cerebral infarction score) of 0, national institute of health stroke scale (nihss) of 15 and mrs (modified rankin score) of 0.The procedure was completed without neurological deterioration reported.Within 24 hours after the procedure showed tici of 2b50 and nihss of 12.After the study procedure to 48 hours post procedure, ct (computed tomography) scan overnight was concerning for right ica (internal carotid artery) dissection likely procedurally related.It was present on patient preoperative film and the patient did have tortuous anatomy.Additionally, there is some contrast staining.The physician did not think this is related to a wire perforation.There is no hemorrhage.The contrast that was infused into an area that was infarcted.Asa medication was administered in response to the patient dissection and the event is still on going.The patient was discharged approximately 5-7 days post procedure with nihss of 12 and mrs of 4 on the day 30 follow up.According to the site, the relationship of the dissection to the subject device (infinity long sheath) and index procedure.No other information was provided.
 
Manufacturer Narrative
Due to the automated manufacturing execution system (mes) 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 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 'patient vessel dissection' is a known and anticipated complication to this type of procedure and patient condition and are listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication will be assigned to this event.
 
Event Description
It was reported that the subject infinity long sheath device was used with other devices to treat the location of proximal face of clot on the right mca (middle cerebral artery) -m1 extending m2.Prior procedure, the patient neurological assessment showed the tici (thrombolysis in cerebral infarction score) of 0, national institute of health stroke scale (nihss) of 15 and mrs (modified rankin score) of 0.The procedure was completed without neurological deterioration reported.Within 24 hours after the procedure showed tici of 2b50 and nihss of 12.After the study procedure to 48 hours post procedure, ct (computed tomography) scan overnight was concerning for right ica (internal carotid artery) dissection likely procedurally related.It was present on patient preoperative film and the patient did have tortuous anatomy.Additionally, there is some contrast staining.The physician did not think this is related to a wire perforation.There is no hemorrhage.The contrast that was infused into an area that was infarcted.Asa medication was administered in response to the patient dissection and the event is still on going.The patient was discharged approximately 5-7 days post procedure with nihss of 12 and mrs of 4 on the day 30 follow up.According to the site, the relationship of the dissection to the subject device (infinity long sheath) and index procedure.No other information was provided.
 
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Brand Name
AXS INFINITY LS 90CM - US
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
MDR Report Key11330444
MDR Text Key232625709
Report Number3008881809-2021-00080
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K152876
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/08/2023
Device Catalogue NumberGEN-10800-90
Device Lot Number22193954
Was Device Available for Evaluation? No
Date Manufacturer Received04/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
3MAX (PENUMBRA); AXS VECTA 71 ((STRYKER); FATHOM .016 (BOSTON SCIENTIFIC); MEDELA DOMINANT FLEX PUMP (STRYKER)
Patient Outcome(s) Other; Required Intervention;
Patient Age77 YR
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