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

Catalog Number	M003XT2750810
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in the case of a patient with left internal carotid artery (ica) occlusion, the physician planned to perform balloon angioplasty followed by stent implantation.After establishing the system, the physician first successfully performed balloon dilation.When attempting to implant the stent, it perforated the side wall of the distal end of the subject microcatheter during delivery, with a section protruding while the main body remained within the lumen of the subject microcatheter.The device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
This is 2 of 2 reports (2nd mdr).
Additional Manufacturer Narrative
This is 2 of 2 reports (2nd mdr).H3 device evaluated by mfg ¿updated.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 stent was stuck inside of the microcatheter.The catheter tip was seen to be damaged.The catheter distal shaft was seen to have hole/perforation.During a functional inspection, the microcatheter was flushed, and the sdw (stent delivery wire) was advanced, but due to damage the sdw was permanently stuck and could not be moved or retracted, even with force.The reported complaint was confirmed based on analysis.The device failed to meet specification 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.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use and no damage was 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.It was reported that when attempting to implant a stent using the subject microcatheter, the stent perforated the side wall of the distal end of the microcatheter during delivery, with a section protruding while the main body remained within the lumen of the microcatheter.During analysis, the device was returned with a stent stuck inside of the microcatheter.The catheter tip was seen to be damaged and the catheter distal shaft was seen to have hole/perforation.The microcatheter was flushed, and the sdw was advanced, but due to damage the sdw was permanently stuck and could not be moved or retracted, even with force.Based on a review of all available information and the analysis of the returned device it is probable that there was force required to advance the stent within the microcatheter, potentially to overcome resistance.An assignable cause of procedural factors will be assigned to the as reported 'device interaction with another device' and the as reported/as analyzed 'catheter shaft has hole/perforation' as well as the as analyzed 'catheter jammed', 'catheter tip damaged' and 'catheter shaft friction' 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/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that in the case of a patient with left internal carotid artery (ica) occlusion, the physician planned to perform balloon angioplasty followed by stent implantation.After establishing the system, the physician first successfully performed balloon dilation.When attempting to implant the stent, it perforated the side wall of the distal end of the subject microcatheter during delivery, with a section protruding while the main body remained within the lumen of the subject microcatheter.The device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: EXCELSIOR XT-27 STD STRAIGHT 150CM
• Common Device Name: 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: 21973862
• Report Number: 3008881809-2025-00257
• Device Sequence Number: 15771536
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: (01)04546540698131(17)270603(10)24985665
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M003XT2750810
• Device Lot Number: 24985665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEUROFORM EZ STENT (STRYKER)
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Race: Asian