MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 1.5MM X 2.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5411520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the coil embolization procedure, when the detachment marker was aligned to detach the subject coil, the coil tail greatly exceeded the microcatheter and the delivery wire of the subject coil appeared to be coming out of the microcatheter distal tip.Contrast was performed and bleeding was observed, therefore the subject coil was immediately detached, and additional coils were implanted as a medical intervention.The third to fifth coils could be implanted without any issue and the bleeding stopped.The procedure was completed successfully.The patient's immediate prognosis was not significantly affected.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.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.It was reported that during the procedure, after the first coil was implanted, when the detachment marker was aligned to detach the second coil (subject coil), the coil tail greatly exceeded the microcatheter and even the delivery wire appeared to be coming out of the microcatheter tip.Contrast was performed and bleeding was observed, so the subject coil was immediately detached, and additional coils were implanted.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the tortuosity of the patient's anatomy was severe, no torque was given where advancing the delivery wire, and the coil was advanced slowly and gently without applying excessive force.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to the as reported event of unexpected movement of device.The as reported event of patient hemorrhage, blood loss with sequelae is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.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.It was reported that during the procedure, after the first coil was implanted, when the detachment marker was aligned to detach the second coil (subject coil), the coil tail greatly exceeded the microcatheter and even the delivery wire appeared to be coming out of the microcatheter tip.Contrast was performed and bleeding was observed, so the subject coil was immediately detached, and additional coils were implanted.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the tortuosity of the patient's anatomy was severe, no torque was given where advancing the delivery wire, and the coil was advanced slowly and gently without applying excessive force.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to the as reported event of unexpected movement of device.The reported events of patient hemorrhage, blood loss with sequelae is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported that during the coil embolization procedure, when the detachment marker was aligned to detach the subject coil, the coil tail greatly exceeded the microcatheter and the delivery wire of the subject coil appeared to be coming out of the microcatheter distal tip.Contrast was performed and bleeding was observed, therefore the subject coil was immediately detached, and additional coils were implanted as a medical intervention.The third to fifth coils could be implanted without any issue and the bleeding stopped.The procedure was completed successfully.The patient's immediate prognosis was not significantly affected.

• Brand Name: TARGET TETRA 1.5MM X 2.0CM
• 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: 20190388
• Report Number: 3008881809-2024-00416
• Device Sequence Number: 7059307
• Product Code: HCG
• UDI-Device Identifier: 07613327580099
• UDI-Public: 07613327580099
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K222533
• 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): 09/30/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TG5411520
• Device Lot Number: 24840704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2024
• 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: INZONE POWER SUPPLY (STRYKER); PHENOM 17 MICROCATHETER (MEDTRONIC); TARGET COILS (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown