MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035442030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Visual Disturbances (2140); Cognitive Changes (2551)

Event Date 10/12/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : the subject device was implanted.

Event Description

It was reported that after 48 hours post study procedure on (b)(6) 2023, the patient was unable to clearly state in right visual field whether the vision was different from the baseline nihss (national institute of health stroke scale) score of 1.Cta (computed tomography angiography) and ct perfusion studies were obtained, and no acute hemorrhage was noted, and vasculature appeared from the patient.The patient was started on stat integrillin with an initial dose of 7.3mg and then placed on an infuse of integrillin of 1/mcg/kg/min.Reassessment of visual fields resulted in a nihss score of 2 for visual fields and overall score of 2.Mri (magnetic resonance imaging) was obtained one day later which showed small occipital pole stroke.The patient was remained in hospital overnight before discharging on (b)(6) 2023.At time of discharge, the patient was able to perform finger counting in all visual fields and nihss was scored of 0.From a medical opinion perspective, the physician attributes stroke to length of procedure due to being a challenging aneurysm.

Manufacturer Narrative

D4 expiration date - added.H4 manufacturing date ¿ added.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.The event description indicates the adverse event was causally related to the index procedure, possibly related to the citadel device and non-investigational stryker device.No device malfunction was reported.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.

Event Description

It was reported that after 48 hours post study procedure on (b)(6) 2023, the patient was unable to clearly state in right visual field whether the vision was different from the baseline nihss (national institute of health stroke scale) score of 1.Cta (computed tomography angiography) and ct perfusion studies were obtained, and no acute hemorrhage was noted, and vasculature appeared from the patient.The patient was started on stat integrillin with an initial dose of 7.3mg and then placed on an infuse of integrillin of 1/mcg/kg/min.Reassessment of visual fields resulted in a nihss score of 2 for visual fields and overall score of 2.Mri (magnetic resonance imaging) was obtained one day later which showed small occipital pole stroke.The patient was remained in hospital overnight before discharging on (b)(6) 2023.At time of discharge, the patient was able to perform finger counting in all visual fields and nihss was scored of 0.From a medical opinion perspective, the physician attributes stroke to length of procedure due to being a challenging aneurysm.

• Brand Name: TARGET 360 NANO 2MM X 3CM
• Type of Device: 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: 18075608
• MDR Text Key: 327475001
• Report Number: 3008881809-2023-00532
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M0035442030
• Device Lot Number: 24261930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EXCELSIOR 1018 (STRYKER)
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White