MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, PERCUTANEOUS

Catalog Number UNK_NEU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vasoconstriction (2126)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

Outcomes attributed to ae: corrected: no other serious (important medical events).Executive summary: updated - received additional information on 22-mar-2021: indicated that the vasospasm was not serious, resolved at the end of the procedure with medical management of ia verapamil.

Event Description

It was reported that the subject axs infinity ls" long sheath device was used with other devices to treat the location of proximal face of clot on the right internal carotid artery - intracranial-t (bifurcation).Prior procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 0, national institute of health stroke scale (nihss) of 17 and mrs (modified rankin score) of 0.During the study procedure, the vasospasm occurred, and it was treated with a slow intra-arterial verapamil infusion.The event was resolved at the same day without symptomatic intracranial hemorrhage or neurological deterioration reported.24 hours post procedure, the patient was assessed having a nihss score of 25.The patient was discharged approximately 5-7 days post procedure with nihss score of 26 and mrs of 5.According to the site, the relationship of the vasospasm to the subject device (axs infinity ls" long sheath), index stroke and index procedure.No other information was provided.Update additional information: received additional information on 22-mar-2021 indicated that the vasospasm was not serious, resolved at the end of the procedure with medical management of ia verapamil.

Manufacturer Narrative

The subject device is unavailable to manufacturer.

Event Description

It was reported that the subject axs infinity ls" long sheath device was used with other devices to treat the location of proximal face of clot on the right internal carotid artery - intracranial-t (bifurcation).Prior procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 0, national institute of health stroke scale (nihss) of 17 and mrs (modified rankin score) of 0.During the study procedure, the vasospasm occurred, and it was treated with a slow intra-arterial verapamil infusion.The event was resolved at the same day without symptomatic intracranial hemorrhage or neurological deterioration reported.24 hours post procedure, the patient was assessed having a nihss score of 25.The patient was discharged approximately 5-7 days post procedure with nihss score of 26 and mrs of 5.According to the site, the relationship of the vasospasm to the subject device (axs infinity ls" long sheath), index stroke and index procedure.No other information was provided.

Manufacturer Narrative

Although the device history record (dhr) 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 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.It was reported that during the procedure, vasospasm occurred which required medical management.Additional information received on 22-mar-2021 indicated that the vasospasm was not serious and resolved at the end of the procedure with medical management of ia verapamil.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.

Event Description

It was reported that the subject axs infinity ls¿ long sheath device was used with other devices to treat the location of proximal face of clot on the right internal carotid artery - intracranial-t (bifurcation).Prior procedure, the patient neurological assessment showed the thrombolysis in cerebral infarction (tici) of 0, national institute of health stroke scale (nihss) of 17 and mrs (modified rankin score) of 0.During the study procedure, the vasospasm occurred, and it was treated with a slow intra-arterial verapamil infusion.The event was resolved at the same day without symptomatic intracranial hemorrhage or neurological deterioration reported.24 hours post procedure, the patient was assessed having a nihss score of 25.The patient was discharged approximately 5-7 days post procedure with nihss score of 26 and mrs of 5.According to the site, the relationship of the vasospasm to the subject device (axs infinity ls¿ long sheath), index stroke and index procedure.No other information was provided.Received additional information on 22-mar-2021 indicated that the vasospasm was not serious, resolved at the end of the procedure with medical management of ia verapamil.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11507378
• MDR Text Key: 247284996
• Report Number: 3008881809-2021-00125
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K152876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 78 YR