MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035425150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the subject device was implanted.
Event or Problem Description
It was reported that post study procedure, the patient experienced intraprocedural thrombus as mild platelet aggregation was noted outside the coil mass.Based on the findings, a bolus infusion of integrilin over 10 minutes was ordered into left ica (internal carotid artery).Follow up imaging was performed, and no filling defect was seen to suggest platelet aggregation.The adverse event was resolved, without sequelae and the patient was neurologically stable at discharge.From a medical opinion perspective, the adverse event (intraprocedural thrombus) was possibly related to the subject coil device, and causally related to the index procedure.
Event or Problem Description
It was reported that post study procedure, the patient experienced intraprocedural thrombus as mild platelet aggregation was noted outside the coil mass.Based on the findings, a bolus infusion of integrilin over 10 minutes was ordered into left ica (internal carotid artery).Follow up imaging was performed, and no filling defect was seen to suggest platelet aggregation.The adverse event was resolved, without sequelae and the patient was neurologically stable at discharge.From a medical opinion perspective, the adverse event (intraprocedural thrombus) was possibly related to the subject coil device, and causally related to the index procedure.
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 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 on the additional information received, there were no difficulties encountered during the procedure and the physician indicated that the target coil performed as intended.An assignable cause of anticipated procedural complication will be assigned to this complaint investigation.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 with the directions for use, product labeling and/or risk documentation files.

• Brand Name: TARGET 360 ULTRA 5MM 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: 18080422
• Report Number: 3008881809-2023-00534
• Device Sequence Number: 7730259
• Product Code: HCG
• UDI-Device Identifier: 04546540675965
• UDI-Public: 04546540675965
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 11/27/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2026
• Device Catalogue Number: M0035425150
• Device Lot Number: 24273876
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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: AXS CATALYST 5 (STRYKER).; GUIDE CATHETER (FUBUKI).; GUIDEWIRE (ARISTOTLE 14).
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White