MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 16MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036121650
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the treatment of right carotid-cavernous fistula, the operator used the microcatheter and the guidewire to navigate to the interior of the fistulous orifice.During the positioning of the subject coil, it detached prematurely and the stent retriever was used to capture it.A 30 minutes surgical delay was reported due to this event.The procedure was completed successfully, no further information available.
Additional Manufacturer Narrative
D9 product available to stryker updated.D9 returned to manufacturer on 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 and functional inspections were not conducted due to device 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.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.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.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 reported event ¿main coil prematurely detached/separated during use¿.
Event or Problem Description
It was reported that during the treatment of right carotid-cavernous fistula, the operator used the microcatheter and the guidewire to navigate to the interior of the fistulous orifice.During the positioning of the subject coil, it detached prematurely and the stent retriever was used to capture it.A 30 minutes surgical delay was reported due to this event.The procedure was completed successfully, no further information available.
Event or Problem Description
It was reported that during the treatment of right carotid-cavernous fistula, the operator used the microcatheter and the guidewire to navigate to the interior of the fistulous orifice.During the positioning of the subject coil, it detached prematurely and the stent retriever was used to capture it.A 30 minutes surgical delay was reported due to this event.The procedure was completed successfully, no further information available.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated h6 method code grid - updated h6 results code grid - updated h6 conclusion code grid - 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 device was returned without the delivery wire.The main coil was seen to be tangled.The main coil was seen to be stretched.The main coil suture was seen to be damaged.The main coil was seen to be broken/fractured.Functional inspection was not carried out.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 based on analysis; however, the analysis results are consistent with the reported event.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 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.This complaint appears to be 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 factors during use.Therefore, a probable cause has been assigned 'procedural factors' to the reported and analyzed event: 'main coil prematurely detached/separated during use' and analyzed events: ¿main coil tangled¿, ¿main coil stretched¿, ¿main coil suture damage¿, and ¿main coil broken/fractured during use¿.

• Brand Name: TARGET XL 360 SOFT 16MM X 50CM
• 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: 19294350
• Report Number: 3008881809-2024-00211
• Device Sequence Number: 15651329
• Product Code: HCG
• UDI-Device Identifier: 04546540711557
• UDI-Public: 04546540711557
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K153658
• 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): 08/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2026
• Device Catalogue Number: M0036121650
• Device Lot Number: 24092500
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 06/26/2024; 07/29/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 07/22/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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: SL-10 MICROCATHETER (STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).; TREVO NXT STENT RETRIEVER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female