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

Catalog Number	M003XT2750810
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a left ophthalmic segment aneurysm procedure, a flow diverter (fd) stent implantation was planned.The operator established access and used a guidewire to advance the subject microcatheter to the m1 segment of the middle carotid artery (mca).Next, the fd stent was delivered through the subject microcatheter to the target lesion.The operator positioned and retracted the subject microcatheter to deploy the stent but found that the stent failed to open.The operator attempted to retract and redeploy the stent but it did not result in its opening.The operator then withdrew the entire stent system out of the patient's anatomy and discovered that the tip of the subject microcatheter had fractured and was encased around the stent, preventing its expansion.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during a left ophthalmic segment aneurysm procedure, a flow diverter (fd) stent implantation was planned.The operator established access and used a guidewire to advance the subject microcatheter to the m1 segment of the middle carotid artery (mca).Next, the fd stent was delivered through the subject microcatheter to the target lesion.The operator positioned and retracted the subject microcatheter to deploy the stent but found that the stent failed to open.The operator attempted to retract and redeploy the stent but it did not result in its opening.The operator then withdrew the entire stent system out of the patient's anatomy and discovered that the tip of the subject microcatheter had fractured and was encased around the stent, preventing its expansion.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4: manufacturing date ¿ added.H3: device evaluated by mfg ¿updated.D4: expiration date - added.D9: product available to stryker ¿ updated.D9: returned to manufacturer on ¿updated.D4: gtin - updated.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 shaft was kinked/bent in multiple areas.The catheter shaft was flat/crushed in multiple areas.The markerband was attached.The outer layer of the shaft was detached and the markerband was exposed.The catheter hub was intact.During functional inspection the catheter was flushed without issue.A 0.0265" mandrel was advanced and friction was felt advancing through the catheter shaft.The reported event is covered in the device direction 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 reported event.The reported defect was confirmed based on analysis of the device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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 patient¿s anatomy was described as moderately tortuous.The catheter shaft was kinked/bent in multiple areas.The catheter shaft was flat/crushed in multiple areas.The markerband was attached.The outer layer of the shaft was detached and the markerband was exposed.The catheter hub was intact.The catheter was flushed without issue.A 0.0265" mandrel was advanced and friction was felt advancing through the catheter shaft.Based on a review of all available information and the analysis of the returned device it is probable the damage to the tip outer layer seems to have happened while force manipulating the catheter to open the flow diverter stent (fds).Multiple proximal & distal kinks/crushes (even with possibly the wire inside the catheter) could be attributed to the excessive pull/push force exerted on the device during use.The reported event 'catheter tip broken/fractured during use' as well as the analysed events: 'catheter shaft kinked/bent', 'catheter shaft flat/crushed', and 'catheter tip broken/fractured during use' 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.

• 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: 22867382
• Report Number: 3008881809-2025-00457
• Device Sequence Number: 15767482
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: (01)04546540698131(17)271203(10)25341115
• 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): 10/17/2025

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: 25341115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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: FLOW DIVERTER STENT (UNKNOWN).
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Race: Asian