MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.0MM X 4.5CM; DEVICE, NUROVASCULAR EMBOLIXATION

Catalog Number	TG5412045
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the proximal part of the subject coil had stretched.The subject main coil had prematurely detached during use and a snare was used to pull out the subject main coil from the artery.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 the proximal part of the subject coil had stretched.The subject main coil had prematurely detached during use and a snare was used to pull out the subject main coil from the artery.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
D9 - product available to stryker - updated.D9 - returned to manufacturer on - updated.H3 - device evaluated by mfg ¿ updated.Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the coil delivery wire was seen to be kinked.The coil proximal contact was seen to be fractured.The main coil was seen to be stretched near the detachment zone (dz).The functional inspection was not performed.The reported event ¿main coil stretched¿ was confirmed during analysis.The reported event ¿coil proximal contact wire broken/fractured¿ was confirmed during analysis.The reported event ¿patient medical or surgical intervention required¿ could not be confirmed as this is a patient related code.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 the proximal part of the subject coil had stretched and the very proximal end of the device was damaged.The main coil was pulled out of the artery with a snare and was fully removed.Additional information provided by the customer indicated that a microcatheter was used with the subject coil and the damage occurred at the end of the procedure.It was also noted that all felt normal until the physician tried to remove the delivery wire (thought it was detached) and then felt that it hadn't fully detached.When the physician went to re-manipulate it, he felt that the coil had stretched and he could not get 1:1 push-pull.The device was returned for analysis, and it was noted that the proximal section of the main coil was stretched near the detachment zone, the coil delivery wire was kinked, and the coil proximal contact was fractured.Based on a review of available information and analysis of the returned device, it is probable that the main coil was stretched due to manipulation against resistance as it was noted that the physician could not get 1:1 push-pull.It is possible that the delivery wire and proximal contact could have been damaged from withdrawing the delivery wire against resistance too quickly.An assignable cause of procedural factors will be assigned to the reported event and analyzed event 'main coil stretched' as well as the reported event 'nv - patient medical or surgical intervention required' since these issues are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use the product performance was limited.An assignable cause of handling damage will be assigned to the reported event and analyzed event 'nv - coil proximal contact wire broken/fractured' as well as the analyzed event 'nv - coil delivery wire kinked/bent' since these issues are likely due to handling of the product or portion of the product during the clinical procedure.

• Brand Name: TARGET TETRA 2.0MM X 4.5CM
• Common Device Name: DEVICE, NUROVASCULAR EMBOLIXATION
• 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: 23589399
• Report Number: 3008881809-2025-00645
• Device Sequence Number: 16010836
• Product Code: HCG
• UDI-Device Identifier: 07613327578591
• UDI-Public: (01)07613327578591(17)280208(10)25464889
• 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): 03/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TG5412045
• Device Lot Number: 25464889
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2025
• 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: EXCELSIOR SL10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown