MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421020
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	08/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during procedure after positioning the subject coil properly into the aneurysm the subject coil didn¿t detach after multiple attempts.When the operator tried to advance the subject coil slightly, the aneurysm ruptured and the subject coil detached in the subarachnoid space.It was also reported that a non-stryker guide catheter had a leak in it that introduced air into the vessel prior to detaching the subject coil.The procedure was stopped right after the aneurysm ruptured and an evd was placed in the patient as a medical intervention.Patient outcome is unknown at this moment.
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.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 reported for 'main coil prematurely detached/separated during use', 'patient aneurysm rupture', and 'main coil failed/unable to detach'.
Event or Problem Description
It was reported that during procedure after positioning the subject coil properly into the aneurysm the subject coil didn¿t detach after multiple attempts.When the operator tried to advance the subject coil slightly, the aneurysm ruptured and the subject coil detached in the subarachnoid space.It was also reported that a non-stryker guide catheter had a leak in it that introduced air into the vessel prior to detaching the subject coil.The procedure was stopped right after the aneurysm ruptured and an evd was placed in the patient as a medical intervention.Patient outcome is unknown at this moment.

• Brand Name: TARGET 360 NANO 1MM X 2CM
• 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: 15435759
• Report Number: 3008881809-2022-00453
• Device Sequence Number: 17601280
• Product Code: HCG
• UDI-Device Identifier: 04546540697967
• UDI-Public: 04546540697967
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 11/14/2022

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: 11/06/2024
• Device Model Number: M0035421020
• Device Catalogue Number: M0035421020
• Device Lot Number: 23276968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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: GUIDE CATHETER (BENCHMARK); INZONE (STRYKER); SL -10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown