MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Catalog Number M0031681900

Device Problems Fracture (1260); Peeled/Delaminated (1454)

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

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the catheter distal shaft was broken/fractured.The distal shaft measured 5.5cm.The radiopaque distal marker band was detached and was encapsulating the concurrent stent.There was polytetrafluoroethylene (ptfe) encapsulating the stent and stent deliver wire (sdw).The stent strut was protruding though the ptfe.The coil from the catheter was wrapped around the sdw.Unable to complete functional test as the sdw could be not be removed.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 event was not confirmed as it¿s unknown what the issue was with the device.The device failed to meet specification when returned for analysis.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device 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 distal shaft was broken/fractured.The distal marker band was detached and was encapsulating the stent.There was ptfe encapsulating the stent and the a strut of the stent was protruding though the ptfe.The most likely cause of the broken catheter shaft was a damaged stent strut broke through the layers of the catheter separating the inner shaft of the catheter and the radiopaque marker band.The damaged strut may have doubled back during deployment/pullback and snagged on the marker band.The as analyzed damage of the catheter shaft broken/fractured during use, catheter ptfe inner lining peeling and ro marker(s) detached/separated/not visible under fluoroscopy will be assigned procedural factors as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and anatomical factors during use, the product performance was limited.An assignable cause of undeterminable was assigned for the reported event of the device problem unknown/unclear as it is unclear what was the reported issue for this complaint.

Event Description

The device was returned for analysis and the investigation of the device revealed that the catheter (subject device) shaft broken/fractured during use, the catheter polytetrafluoroethylene (ptfe) inner lining peeling, radiopaque (ro) marker(s) detached/separated/not visible under fluoroscopy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 45 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: 18735649
• MDR Text Key: 335859495
• Report Number: 3008881809-2024-00069
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0031681900
• Device Lot Number: 24161833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2023
• 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: NEUROFORM ATLAS STENT (STRYKER)
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Race: Asian