MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.5MM X 3.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5412535
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject coil was used for coiling an aneurysm off the basilar artery and sca.After deploying about 75% of the subject coil, it wouldn't stay in the aneurysm after a few attempts and thus, the subject coil along with the microcatheter was withdrawn and the resistance was encountered, ultimately not allowing the subject coil to be pulled back into the microcatheter.The subject coil was partially deployed through the guide catheter.The subject coil was replaced with a smaller size, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.Upon examination outside of the patient; the subject coil had formed a knot on itself.
Event or Problem Description
It was reported that the subject coil was used for coiling an aneurysm off the basilar artery and sca.After deploying about 75% of the subject coil, it wouldn't stay in the aneurysm after a few attempts and thus, the subject coil along with the microcatheter was withdrawn and the resistance was encountered, ultimately not allowing the subject coil to be pulled back into the microcatheter.The subject coil was partially deployed through the guide catheter.The subject coil was replaced with a smaller size, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.Upon examination outside of the patient; the subject coil had formed a knot on itself.
Additional Manufacturer Narrative
D4 expiration date ¿ added d4 gtin- added h4 manufacturing date ¿ added d10 product available to stryker / returned to manufacturer on ¿ updated h3 device evaluated by mfg ¿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.Visual inspection was performed as just the (subject coil) distal of 35cm of the delivery wire was returned.The coil delivery wire was found to be broken/fractured and kinked/bent.The main coil was found to be kinked/bent.A functional inspection could not be performed due to the break/fracture on the delivery wire.The reported 'main coil prematurely detached/separated during use' was not confirmed.The reported 'coil difficult to remove/withdraw from catheter' could not be replicated during device analysis due to a subject coil damage; however, the analysis results were consistent with the reported event.The subject device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the subject 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.It was reported that during a coiling procedure, resistance was encountered when pulling back on the delivery wire and the coil (subject device) could not be pulled back into the straight sl-10 microcatheter.The sl-10 microcatheter.Was removed with the subject coil partially deployed by pulling both together back through the guide catheter (sofia).Upon examination outside the patient, the subject coil had formed a knot on itself.Additional information provided by the customer indicated that the subject device was inspected and confirmed to be in good condition during preparation, the subject device was prepared as per the dfu, and continuous flush was maintained.Additionally, it was noted that vertebral artery access was very tortuous.The sofia could only be advanced halfway up, with the sl-10 microcatheter having to make it up the rest of the way.Just the distal 35cm of the delivery wire was returned.During visual inspection, the coil delivery wire was found to be broken/fractured and kinked/bent.The main coil was found to be kinked/bent.A functional inspection could not be performed due to the break/fracture on the delivery wire; however, the analysis results were consistent with the reported event.As the main coil was still attached to the delivery wire, the as reported 'main coil prematurely detached/separated during use' was not confirmed.Since it was noted that vertebral artery access was very tortuous and the sofia guide catheter could only be advanced halfway up, it is probable that the microcatheter did not have enough support when accessing the aneurysm.As a result, it is possible the microcatheter may have gotten kinked during the procedure, causing resistance and the subsequent fracture when the delivery wire was retracted through the catheter.An assignable cause of procedural factors will be assigned to the as reported ¿coil difficult to remove/withdraw from catheter' and the as analyzed 'main coil kinked/bent', 'coil delivery wire kinked/bent' and ¿coil delivery wire broken/fractured during use' since these issues are 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 and/or anatomical factors during use.

• Brand Name: TARGET TETRA 2.5MM X 3.5CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 22439301
• Report Number: 3008881809-2025-00378
• Device Sequence Number: 4593503
• Product Code: HCG
• UDI-Device Identifier: 07613327578614
• UDI-Public: (01)07613327578614(17)270603(10)24985176
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K242243
• 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): 09/15/2025

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: TG5412535
• Device Lot Number: 24985176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/15/2025
• 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: SL10 MICROCATHETER (STRYKER).; SOFIA GUIDING CATHETERER.
• Patient Sex: Unknown