MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.5MM X 8.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5413580
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paralysis (1997); Thrombosis/Thrombus (4440)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 24 hours post cranial neurovascular procedure with subject coil the patient presented with a new deficit (left hemiplegia).The patient was taken for further studies where clot formation was noticed on the subject coil that had been implanted.The patient is currently bed - ridden and no further information is available.
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 the patient presented with a new deficit (left hemiplegia) within 24hrs post procedure.The patient was taken for further studies where clot formation was noticed on the subject coil that had been implanted.The reported events of patient vessel thrombosis and patient neurological deficit are known and anticipated complications to these types of procedures and patient condition and are 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 24 hours post cranial neurovascular procedure with subject coil the patient presented with a new deficit (left hemiplegia).The patient was taken for further studies where clot formation was noticed on the subject coil that had been implanted.The patient is currently bed - ridden and no further information is available.

• Brand Name: TARGET TETRA 3.5MM X 8.0CM
• 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: 20526605
• Report Number: 3008881809-2024-00503
• Device Sequence Number: 12792072
• Product Code: HCG
• UDI-Device Identifier: 07613327578690
• UDI-Public: (01)07613327578690(17)270205(10)24760573
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 11/25/2024

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: TG5413580
• Device Lot Number: 24760573
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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: TARGET COIL (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female