MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD PRE-SHAPED 150CM; CATHETER, PERCUTANEOUS

Model Number M003XT2750910

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that a neurovascular surgical procedure was performed on a patient with ninety percent stenosis in right mca (middle carotid artery).Initially a guidewire was delivered to pass the target lesion and then the target lesion was dilated using a balloon.Later the subject microcatheter was advanced along with the guidewire to reach the distal target lesion and then prepared to deploy the stent.During delivery the stent encountered resistance advancing through the subject microcatheter.The stent was retrieved and tried again but resistance was still encountered.When the operator tried to withdraw the stent again, this time the stent could not be retrieved.When the operator checked under dsa it was found that the stent was stuck in subject microcatheter at the anatomical location of tail of ica (internal carotid artery)and hence the stent was not able to reach the target lesion.When changed to another view, it was found that the tip of the stent was deployed.The operator withdrew the stent along with the subject microcatheter and the guidewire out of patient's body and found that the stent had perforated the tip of subject microcatheter, hence the tip of the stent was deployed out of subject microcatheter and the rest of the part was still stuck inside the lumen of subject microcatheter.The stent, guide wire and subject microcatheter were replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Event Description

It was reported that a neurovascular surgical procedure was performed on a patient with ninety percent stenosis in right mca (middle carotid artery).Initially a guidewire was delivered to pass the target lesion and then the target lesion was dilated using a balloon.Later the subject microcatheter was advanced along with the guidewire to reach the distal target lesion and then prepared to deploy the stent.During delivery the stent encountered resistance advancing through the subject microcatheter.The stent was retrieved and tried again but resistance was still encountered.When the operator tried to withdraw the stent again, this time the stent could not be retrieved.When the operator checked under dsa it was found that the stent was stuck in subject microcatheter at the anatomical location of tail of ica (internal carotid artery)and hence the stent was not able to reach the target lesion.When changed to another view, it was found that the tip of the stent was deployed.The operator withdrew the stent along with the subject microcatheter and the guidewire out of patient's body and found that the stent had perforated the tip of subject microcatheter, hence the tip of the stent was deployed out of subject microcatheter and the rest of the part was still stuck inside the lumen of subject microcatheter.The stent, guide wire and subject microcatheter were replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H3 summary attached - updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date ¿ added.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the device was returned together with the ez stent and sdw.The catheter was found to be damaged/punctured by sdw.The catheter shaft was found to be deformed.Functional inspection: catheter shaft has hole/perforation functional test ¿ confirmed during the visual inspection device interaction with another device functional test ¿ confirmed during visual inspection catheter shaft friction functional test ¿ unable to perform the test due to condition of 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.Additional information provided by the customer indicated that the device was prepared as per the dfu and continuous flush was maintained throughout the clinical procedure.Also additional information indicated that the patient anatomy was severely tortuous which would have contributed to the event.It was seen that the catheter shaft was deformed which would have caused friction during the procedure.Also the catheter shaft may have been perforated when the friction was felt within the catheter shaft, force may have been applied when advancing the neuroform stent.Based on the investigation results and available information, an assignable cause of procedural factors will be assigned to the as reported/as analyzed catheter shaft has hole/perforation, as reported device interaction with another device and catheter shaft friction as well as the as analyzed catheter shaft deformed.

• Brand Name: EXCELSIOR XT-27 STD PRE-SHAPED 150CM
• Type of Device: 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: 13061523
• MDR Text Key: 282632254
• Report Number: 3008881809-2021-00543
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04546540698155
• UDI-Public: 04546540698155
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113778
• 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
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2024
• Device Model Number: M003XT2750910
• Device Catalogue Number: M003XT2750910
• Device Lot Number: 22795015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2021
• 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: GATEWAY BALLOON (STRYKER); NEUROFORM EZ STENT (STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER)
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Race: Asian