MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 4MM X 12CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036124120
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that after the study procedure within 48 hours, the patient had experienced with ischemic stroke at basilar tip.The outcome of stroke is still on going.The patient was discharged 5 days after the procedure with the modified rankin scale (mrs) of 1 and national institute of health stroke scale (nihss) of 0.No other information was provided.
Event or Problem Description
It was reported that after the study procedure within 48 hours, the patient had experienced with ischemic stroke at basilar tip.The outcome of stroke is still on going.The patient was discharged 5 days after the procedure with the modified rankin scale (mrs) of 1 and national institute of health stroke scale (nihss) of 0.No other information was provided.Update information: received additional information was received on 10-mar-2023 indicated that the adverse event stroke is still going.In the physician opinion, the stroke was caused by the herniated target coil (subject device) covering the right sca origin and thrombus formation and patients pre existing atherosclerotic disease.The anatomical of the stroke was located at basilar tip.
Additional Manufacturer Narrative
B1 adverse event/product problem - corrected from adverse event to adverse event and product problem b5 executive summary - updated f10/h6 device code grid - corrected to migration.
Event or Problem Description
It was reported that after the study procedure within 48 hours, the patient had experienced with ischemic stroke at basilar tip.The outcome of stroke is still on going.The patient was discharged 5 days after the procedure with the modified rankin scale (mrs) of 1 and national institute of health stroke scale (nihss) of 0.No other information was provided.Update information: received additional information was received on 10-mar-2023 indicated that the adverse event stroke is still going.In the physician opinion, the stroke was caused by the herniated target coil (subject device) covering the right sca origin and thrombus formation and patients pre existing atherosclerotic disease.The anatomical of the stroke was located at basilar tip.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿updated.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.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 and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.

• Brand Name: TARGET XL 360 SOFT 4MM X 12CM
• 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: 16493334
• Report Number: 3008881809-2023-00110
• Device Sequence Number: 6374559
• Product Code: HCG
• UDI-Device Identifier: 07613327128338
• UDI-Public: 07613327128338
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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): 04/13/2023

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: 08/03/2025
• Device Model Number: M0036124120
• Device Catalogue Number: M0036124120
• Device Lot Number: 23797362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 03/10/2023; 04/12/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 03/29/2023; 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: White