MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035424150
Medical Device Problem Codes	Fracture (1260); Expulsion (2933); Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/23/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during acom large neck ruptured aneurysm procedure, after the physician put the coil (subject device), he noticed that it was too long so decided to remove it.During withdrawal the coil (subject device) was prematurely detached and the pusher was broken in two pieces (from the radiopaque market proximally was in his hand, and the distal portion of the pusher was in the artery).The coil (subject device) was the majority in the aneurysm, 2cm in a1 and the remaining part of the pusher in a1-syphon.The physician tried to remove with a lazzoo without success.There was a surgical delay of unknown duration.Additional information received on 02- mar-2023 included that patient passed away.No further information is available.
Additional Manufacturer Narrative
Section h10 and/or 11 additional mfg narrative - corrected 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 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.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.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 was assigned.
Event or Problem Description
It was reported that during acom large neck ruptured aneurysm procedure, after the physician put the coil (subject device), he noticed that it was too long so decided to remove it.During withdrawal the coil (subject device) was prematurely detached and the pusher was broken in two pieces (from the radiopaque market proximally was in his hand, and the distal portion of the pusher was in the artery).The coil (subject device) was the majority in the aneurysm, 2cm in a1 and the remaining part of the pusher in a1-syphon.The physician tried to remove with a lazzoo without success.There was a surgical delay of unknown duration.Additional information received on 02- mar-2023 included that patient passed away.No further information is available.
Additional Manufacturer Narrative
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 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.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.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 was assigned.Information received indicated that the customer indicated that the dfu was not followed.However as no additional information was provided it cannot be determined if this contributed to the reported event.
Event or Problem Description
It was reported that during acom large neck ruptured aneurysm procedure, after the physician put the coil (subject device), he noticed that it was too long so decided to remove it.During withdrawal the coil (subject device) was prematurely detached and the pusher was broken in two pieces (from the radiopaque market proximally was in his hand, and the distal portion of the pusher was in the artery).The coil (subject device) was the majority in the aneurysm, 2cm in a1 and the remaining part of the pusher in a1-syphon.The physician tried to remove with a lazzoo without success.There was a surgical delay of unknown duration.Additional information received on 02- mar-2023 included that patient passed away.No further information is available.

• Brand Name: TARGET 360 ULTRA 4MM X 15CM
• 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: 16507952
• Report Number: 3008881809-2023-00114
• Device Sequence Number: 17604542
• Product Code: HCG
• UDI-Device Identifier: 04546540675941
• UDI-Public: 04546540675941
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/07/2023

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: 03/26/2024
• Device Model Number: M0035424150
• Device Catalogue Number: M0035424150
• Device Lot Number: 22816428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 05/03/2023; 07/18/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 05/24/2023; 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2021
• 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: HCP PHEGASUS STENT (NON-STRYKER).; SL10 MICROCATHETER (STRYKER).; TARGET COILS (STRYKER).
• Outcome Attributed to Adverse Event: Other; Death; Required Intervention
• Patient Sex: Unknown