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

Catalog Number	M0035421020
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Ruptured Aneurysm (4436)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during the procedure the subject coil was delivered successfully into the aneurysm located at the basilar artery.A subsequent run disclosed that the subject coil herniated out of the aneurysm and migrated to the distal left posterior cerebral artery (pca).Aspiration was performed to retrieve the coil by the physician, but failed.A run disclosed that the aneurysm and basilar artery ruptured.There was an increase in the patients blood pressure, so the physician stopped attempting to retrieve the subject coil.There was a surgical delay of unknown time and the patient's last condition was intubated.No other information is available.
Additional Manufacturer Narrative
H3 other text : the device is not available for evaluation.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.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 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.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to the reported event of main coil migration, un-retrieved device fragments and patient aneurysm rupture.
Event or Problem Description
It was reported during the procedure the subject coil was delivered successfully into the aneurysm located at the basilar artery.A subsequent run disclosed that the subject coil herniated out of the aneurysm and migrated to the distal left posterior cerebral artery (pca).Aspiration was performed to retrieve the coil by the physician, but failed.A run disclosed that the aneurysm and basilar artery ruptured.There was an increase in the patients blood pressure, so the physician stopped attempting to retrieve the subject coil.There was a surgical delay of unknown time and the patient's last condition was intubated.No other information is available.

• 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: 19216919
• Report Number: 3008881809-2024-00185
• Device Sequence Number: 12493347
• 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): 07/08/2024

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: M0035421020
• Device Lot Number: 24682565
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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: 3MAX160 ASPIRATION CATHETER (UNKNOWN); AXS VECTA 46 ASPIRATION CATHETER (STRYKER); EXCELSIOR SL-10 CATHETER (STRYKER); TRANSFORM BALLOON CATHETER (STRYKER); TREVO NXT RETRIEVER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown