MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 9MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036129300
Medical Device Problem Codes	Fracture (1260); Migration (4003); Premature Separation (4045)
Health Effect - Clinical Codes	Stroke/CVA (1770); Vasoconstriction (2126)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the basilar tip aneurysm procedure, the physician reported that they wanted to replace the size of the subject coil as they felt it was too big.The physician had to reposition the subject coil several times.The subject coil stretched upon withdrawal of the microcatheter and the subject coil fractured and detached prematurely in the patient's vessel.The distal section of the subject coil remained in the dome of the aneurysm and the remainder of the subject coil remained in the patient's vessel.The patient suffered from a infarct cerebellum as a result of the event and was prescribed antiplatelet medication (pletaal tab 100mg, nimotop tab 6x60mm, and manitol 4x150cc).The patient status is stable with a glasgow comma score (gcs) of 15.
Event or Problem Description
It was reported that during the basilar tip aneurysm procedure, the physician reported that they wanted to replace the size of the subject coil as they felt it was too big.The physician had to reposition the subject coil several times.The subject coil stretched upon withdrawal of the microcatheter and the subject coil fractured and detached prematurely in the patient's vessel.The distal section of the subject coil remained in the dome of the aneurysm and the remainder of the subject coil remained in the patient's vessel.The patient suffered from a infarct cerebellum as a result of the event and was prescribed antiplatelet medication (pletaal tab 100mg, nimotop tab 6x60mm, and manitol 4x150cc).The patient status is stable with a glasgow comma score (gcs) of 15.
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 the subject coil detached prematurely and fractured in the parent vessel.The subject coil was protruding from the aneurysm.The patient suffered from a cerebellar infarction and received additional medication as a result of the event.Additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use and was prepared as per the dfu, continuous flush was maintained throughout the procedure, a microcatheter was used with the subject coil, the coil was not advanced or retracted with force, and the anatomy was tortuous.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, an assignable cause of undeterminable was assigned to the as reported events of main coil stretched, main coil prematurely detached/separated during use, main coil broken/fractured during use, main coil protrusion, patient vasospasm serious and patient stroke.

• Brand Name: TARGET XL 360 SOFT 9MM 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: 19493739
• Report Number: 3008881809-2024-00258
• Device Sequence Number: 7107385
• Product Code: HCG
• UDI-Device Identifier: 04546540711618
• UDI-Public: 04546540711618
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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 Catalogue Number: M0036129300
• Device Lot Number: 24799224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/08/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• 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); SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 43 YR
• Patient Sex: Male