MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 7 .068IN ID X 132CM - CE; CATHETER, THROMBUS RETRIEVER

Catalog Number IC068132A

Device Problems Component Missing (2306); Unclear Information (4052)

Patient Problems Stroke/CVA (1770); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

It was reported that during an acute ischemic stroke procedure a distal part (distal marker) of the catheter (subject device) peeled off / teared off.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

This is 2 of 2 reports (for 2nd mdr) the device is not available to the manufacturer.

Event Description

It was reported that during an acute ischemic stroke procedure a distal part (distal marker) of the catheter (subject device) peeled off / tore off due to extreme friction when pulling the catheter (subject device) back, the distal tip tore apart.The reason could have been a kink of the catheter (subject device) and/or the long sheath.The resistance was encountered at the distal/terminal segment of the internal carotid artery during the procedure.However the issue resulted in an additional infarction of the anterior cerebral artery territory and in combination with the initial infarction of the middle cerebral artery resulted in a malignant infarction.A snare was used as a medical intervention to remove the detached marker but without success.After numerous unsuccessful maneuvers to remove the dislocated tip, the procedure was stopped.Patient-reported to have passed away three days after the procedure.The relationship of patient death to the catheter (subject device) and the associated procedure was related to the catheter (subject device).

Manufacturer Narrative

This is 2 of 2 reports ( for 2nd supplemental mdr ).A2: age at time of event/age units (patient) ¿ added.A3: gender ¿ added.A4: weight/weight unites - added.B1: adverse event/product problem - updated from product problem to adverse event and product problem.B2: outcomes attributed to ae - added death, other serious (important medical events), and required intervention to prevent permanent impairment/damage (devices).B5: executive summary - updated.H1: type of reportable event - updated from malfunction to death.H2: follow up type ¿ added additional information and correction.F10: / h6: health impact code grid - health effect - impact code - updated.F10: / h6: clinical signs code grid - health effect - clinical code - updated.

Manufacturer Narrative

H4 manufacturing date ¿ added.D4 expiration date - added.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 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 for analysis.Therefore, the as reported cannot be confirmed.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 Description

It was reported that during an acute ischemic stroke procedure a distal part (distal marker) of the catheter (subject device) peeled off / teared off.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

This is 2 of 2 reports (for 3rd supplemental mdr).Section b1 adverse event/product problem - corrected - no product problem.Section h1 type of reportable event - corrected - no malfunction.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported that during an acute ischemic stroke procedure a distal part (distal marker) of the catheter (subject device) peeled off / tore off due to extreme friction when pulling the catheter (subject device) back, the distal tip tore apart.The reason could have been a kink of the catheter (subject device) and/or the long sheath.The resistance was encountered at the distal/terminal segment of the internal carotid artery during the procedure.However the issue resulted in an additional infarction of the anterior cerebral artery territory and in combination with the initial infarction of the middle cerebral artery resulted in a malignant infarction.A snare was used as a medical intervention to remove the detached marker but without success.After numerous unsuccessful maneuvers to remove the dislocated tip, the procedure was stopped.Patient-reported to have passed away three days after the procedure.The relationship of patient death to the catheter (subject device) and the associated procedure was related to the catheter (subject device).Received additional information on 25-march-2022 confirmed that the second catheter (subject device) is not related to reported event (distal marker peeled off / teared off and not connected to the patient's death).There was no clinical consequence to the patient reported as a result of this event.

• Brand Name: AXS CATALYST 7 .068IN ID X 132CM - CE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• 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: 12904580
• MDR Text Key: 284523288
• Report Number: 3008881809-2021-00502
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K183464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2022
• Device Catalogue Number: IC068132A
• Device Lot Number: 22550440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CATALYST 7 (STRYKER MANUFACTURER).
• Patient Outcome(s): Required Intervention; Death; Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 70 KG