MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035466300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during posterior inferior cerebellar artery procedure, when delivering the subject coil in the microcatheter, the resistance was encountered, and the subject coil was broken.Part of the strand of the subject coil was left inside the patient and required endovascular coiling intervention and caused 35 minutes surgical delay.Post procedure, the patient is moderately active.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 doctor experienced resistance and the coil broke inside the patient and part of the coil remained inside the patient.No anomalies were noted to the device packaging and there is no indication of a use error.The anatomy was described as moderate, noticeably bending.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.
Event or Problem Description
It was reported that during posterior inferior cerebellar artery procedure, when delivering the subject coil in the microcatheter, the resistance was encountered, and the subject coil was broken.Part of the strand of the subject coil was left inside the patient and required endovascular coiling intervention and caused 35 minutes surgical delay.Post procedure, the patient is moderately active.
Event or Problem Description
It was reported that during posterior inferior cerebellar artery procedure, when delivering the subject coil in the microcatheter, the resistance was encountered, and the subject coil was broken.Part of the strand of the subject coil was left inside the patient and required endovascular coiling intervention and caused 35 minutes surgical delay.Post procedure, the patient is moderately active.
Additional Manufacturer Narrative
The subject device was returned as the coil delivery wire was found to be kinked/bent.The main coil was found to be prematurely detached/separate from the coil delivery wire.The main coil was not returned.Functional test was not performed as the main coil was not returned.The reported complaint was confirmed based on device analysis.The subject device failed to meet specifications 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.It was reported that the doctor experienced resistance, and the main coil broke inside the patient and part of the coil remained inside the patient.No anomalies were noted to the subject device packaging and there is no indication of a use error.The anatomy was described as moderate, noticeably bending.Only the subject delivery wire was returned for analysis, and it was determined that the main coil was prematurely detached/separated.As the main coil was not returned it could not be confirmed if the coil had fractured.Therefore, an assignable cause of undeterminable will be assigned to the reported ¿main coil broken/fractured during use¿, ¿un-retrieved device fragments¿.An assignable cause of procedural factors will be assigned to the reported ¿coil in catheter friction¿ and the analyzed ¿main coil prematurely detached/separated during use¿.The issue is associated with a product that meets stryker design and manufacture 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 analyzed ¿coil delivery wire kinked/bent¿ as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• Brand Name: TARGET 360 STANDARD 6MM X 30CM
• 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: 20730260
• Report Number: 3008881809-2024-00551
• Device Sequence Number: 8395568
• Product Code: HCG
• UDI-Device Identifier: 07613252239444
• UDI-Public: (01)07613252239444(17)270219(10)24798754
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K112385
• 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,Followup
• Report Date (Section B): 03/10/2025

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: M0035466300
• Device Lot Number: 24798754
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 01/03/2025; 03/10/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/10/2025; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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: PHENOM 17 CATHETER.; SYNCHRO GUIDEWIRE (STRYKER).
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female