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

Catalog Number IC068132A

Device Problem Component Missing (2306)

Patient Problems Stroke/CVA (1770); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  Death  

Manufacturer Narrative

This is 1 of 2 reports (for 1st 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.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

This is 1 of 2 reports ( for 1st supplemental mdr ).Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the distal marker band was seen to be detached and not returned, and the catheter shaft was seen to be stretched.A functional test was not required as the defect was confirmed.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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 catheter shaft was seen to be stretched and also the distal marker band was seen to be detached and not returned.Therefore, the as reported can be confirmed.Due to the breakage, therefore the ro marker detached.The as reported as well as the as analyzed will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

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.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the distal marker band was seen to be detached and not returned, the catheter shaft was seen to be stretched.During a functional inspection, the catheter was flushed, and a patency mandrel was advanced through with friction felt while advancing and worse through the stretched part of the catheter shaft.The product was returned, and the as analyzed codes listed in the below product problem code(s) grid were found.The reported catheter shaft kinked/bent was not confirmed during analysis.The reported catheter shaft difficulty advancing/removing could not be confirmed; however, the analysis results are consistent with the reported event.The reported ro marker(s) detached/separated, catheter shaft friction, un-retrieved device fragments was confirmed during analysis.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.Additional information provided by the customer indicated that patient died three days after procedure.A snare device used to remove the detached marker, but procedure was unsuccessful.In physician's opinion, 'the teared catheter tip resulted in an additional infarction of the anterior cerebral artery territory.In combination with the initial infarction of the middle cerebral artery resulted in a malignant infarction'.The device prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The catheter shaft was seen to be stretched and also the distal marker band was seen to be detached and not returned.Therefore, the as reported can be confirmed.The as reported as well as the as analyzed will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.An assignable cause of 'not confirmed' was assigned to the reported defect 'catheter shaft kinked/bent' as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.

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 1 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.

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).

• 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: 12903976
• MDR Text Key: 281594270
• Report Number: 3008881809-2021-00501
• 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: 03/31/2022

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: 09/07/2022
• Device Catalogue Number: IC068132A
• Device Lot Number: 22437054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2020
• 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