MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS INFINITY LS PLUS .091IN ID X 90CM-US; CATHETER, PERCUTANEOUS

Model Number	INC-11196-90
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during evt (endovascular thrombectomy) procedure, in a patient who had a difficult aortic arch and cervical ica (internal carotid artery) tandem occlusion, there was extreme kinking of the catheter (subject device) in the aortic arch.This was noticed during the second pass when an intermediate catheter was unable to be advanced within the catheter (subject device), stent retriever was deployed in m1.Withdrew the system into the aortic arch and pulled out the stent retriever.The intermediate catheter would not come out from the kinked catheter.It was not possible to straighten out this kink in the aortic arch, despite attempts to pass a wire.A snare was passed from the radial artery to snare the catheter (subject device) from the top and pulled the catheter (subject device) from the femoral access site.This pulled apart the catheter (subject device) and removed the guide catheter (subject device) through the 8f sheath, but the catheter (subject device) became unwound/split apart during this process.There was 60-90 minutes surgical delay.The evt procedure was terminated early.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 lot # - corrected from 18693-01 to unknown.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 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 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.As per the event, the patient had tortuous anatomy, and this could be the reason why subject catheter kinked.Despite the kink in subject catheter, it is not known, if any resistance was noticed while inserting the vecta inside subject catheter.It could have happened that extreme force was applied on vecta due to which vecta got stuck inside subject catheter.Further, the subject catheter was pulled from two side using the snare device, and that resulted in breaking and stretching of the subject catheter as shown in the picture.It is more than likely that procedural factors caused the damage, since the product was not returned, we cannot be definite about the conclusion.A complaint history review could not be completed because the lot number is unknown.A bi-annual trend review is conducted for all as reported and as analyzed codes.All identified trends are investigated and reviewed at crb (complaint review board).The device was not returned as it was discarded, but the as per the picture provided there was blood inside the infinity.The device was seen extremely stretched and broken.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.
Event or Problem Description
B5 - it was reported that during evt (endovascular thrombectomy) procedure, in a patient who had a difficult aortic arch and cervical ica (internal carotid artery) tandem occlusion, there was extreme kinking of the catheter (subject device) in the aortic arch.This was noticed during the second pass when an intermediate catheter was unable to be advanced within the catheter (subject device), stent retriever was deployed in m1.Withdrew the system into the aortic arch and pulled out the stent retriever.The intermediate catheter would not come out from the kinked catheter.It was not possible to straighten out this kink in the aortic arch, despite attempts to pass a wire.A snare was passed from the radial artery to snare the catheter (subject device) from the top and pulled the catheter (subject device) from the femoral access site.This pulled apart the catheter (subject device) and removed the guide catheter (subject device) through the 8f sheath, but the catheter (subject device) became unwound/split apart during this process.There was 60-90 minutes surgical delay.The evt procedure was terminated early.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.D4 lot # - corrected from unknown to 18015-01.Due to the automated mes (manufacturing execution system) system 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 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.As per the event, the patient had tortuous anatomy, and this could be the reason why infinity kinked.Despite the kink in subject catheter, it is not known, if any resistance was noticed while inserting the vecta inside subject catheter.It could have happened that extreme force was applied on vecta due to which vecta got stuck inside subject catheter.Further, the subject catheter was pulled from two side using the snare device, and that resulted in breaking and stretching of the subject catheter as shown in the picture.It is more than likely that procedural factors caused the damage, since the product was not returned, we cannot be definite about the conclusion.The device was not returned as it was discarded, but the as per the picture provided there was blood inside the infinity.The device was seen extremely stretched and broken.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.
Event or Problem Description
B5 - it was reported that during evt (endovascular thrombectomy) procedure, in a patient who had a difficult aortic arch and cervical ica (internal carotid artery) tandem occlusion, there was extreme kinking of the catheter (subject device) in the aortic arch.This was noticed during the second pass when an intermediate catheter was unable to be advanced within the catheter (subject device), stent retriever was deployed in m1.Withdrew the system into the aortic arch and pulled out the stent retriever.The intermediate catheter would not come out from the kinked catheter.It was not possible to straighten out this kink in the aortic arch, despite attempts to pass a wire.A snare was passed from the radial artery to snare the catheter (subject device) from the top and pulled the catheter (subject device) from the femoral access site.This pulled apart the catheter (subject device) and removed the guide catheter (subject device) through the 8f sheath, but the catheter (subject device) became unwound/split apart during this process.There was 60-90 minutes surgical delay.The evt procedure was terminated early.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 - gtin - corrected pma/510(k) - g4 - corrected based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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 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.It was reported that there was an issue with the subject catheter during a procedure.Ous update jan 10/23: during endovascular thrombectomy (evt), with a patient who had a difficult aortic arch and cervical internal carotid artery (ica) tandem occlusion, there was extreme kinking of the subject catheter in the aortic arch.This was noticed during our second pass when we were unable to advance the aspiration catheter within the subject catheter (retriever deployed in the m1 segment).We withdrew the system into the aortic arch and removed the stent retriever.The aspiration catheter could not be removed from the kinked subject catheter.It was also not possible to straighten out the kink in the aortic arch, despite attempts to pass a wire.The interventional radiology (ir) team punctured the left radial artery, snared the subject catheter from the top, and pulled it out through the femoral access site.This maneuver caused the subject catheter to split apart, allowing the catheter to be removed through the 8f sheath, but the subject catheter became unwound and damaged in the process.There were no adverse consequences other than the early termination of the evt procedure.No additional medical intervention was required, but the physician had to snare the subject catheter to remove it from the patient.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.
Event or Problem Description
B5 - it was reported that during evt (endovascular thrombectomy) procedure, in a patient who had a difficult aortic arch and cervical ica (internal carotid artery) tandem occlusion, there was extreme kinking of the catheter (subject device) in the aortic arch.This was noticed during the second pass when an intermediate catheter was unable to be advanced within the catheter (subject device), stent retriever was deployed in m1.Withdrew the system into the aortic arch and pulled out the stent retriever.The intermediate catheter would not come out from the kinked catheter.It was not possible to straighten out this kink in the aortic arch, despite attempts to pass a wire.A snare was passed from the radial artery to snare the catheter (subject device) from the top and pulled the catheter (subject device) from the femoral access site.This pulled apart the catheter (subject device) and removed the guide catheter (subject device) through the 8f sheath, but the catheter (subject device) became unwound/split apart during this process.There was 60-90 minutes surgical delay.The evt procedure was terminated early.No clinical consequences were reported to the patient due to this event.

• Brand Name: AXS INFINITY LS PLUS .091IN ID X 90CM-US
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 16261065
• Report Number: 3008881809-2023-00043
• Device Sequence Number: 20508417
• Product Code: DQY
• UDI-Device Identifier: 07613327459203
• UDI-Public: (01)07613327459203(17)240828(10)18015-01
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172468
• 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,Followup,Followup
• Report Date (Section B): 01/15/2025

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 Expiration Date: 08/28/2024
• Device Model Number: INC-11196-90
• Device Catalogue Number: INC-11196-90
• Device Lot Number: 18015-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 04/05/2023; 04/28/2023; 12/30/2024
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 04/11/2023; 05/03/2023; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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: 8F SHEATH (STRYKER).; TREVO STENT RETRIEVER (STRYKER).; VECTA CATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown