MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035473060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neuropathy (1983); Cerebral Edema (4403)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the 3 of 3 mdrs h3 other text : the device remains implanted inside the patient's vasculature.
Event or Problem Description
It was reported that during an endovascular procedure for a ruptured aneurysm, physician used the subject coil and flow diverting stent to treat the patient.Post procedure on (b)(6) 2023, patient was readmitted due to fine motor disturbance of right hand since (b)(6), facialis weakness on right hand.Multifocal subcortical edema was notice in the ct (computed tomography) and mri (magnetic resonance imaging).According the physician it is caused by contact allergy (new) type iv to nickel + cobalt.No additional information available.
Event or Problem Description
It was reported that during an endovascular procedure for a ruptured aneurysm, physician used the subject coil and flow diverting stent to treat the patient.Post procedure on (b)(6) 2023 patient was readmitted due to fine motor disturbance of right hand since (b)(6) 2023.Facialis weakness on right hand.Multifocal subcortical edema was notice in the ct (computed tomography) and mri (magnetic resonance imaging).According the physician it is caused by contact allergy (new) type iv to nickel + cobalt.No additional information available.
Additional Manufacturer Narrative
This is the 3 of 3 mdrs.H4 manufacturing date ¿ added.D4 expiration date ¿ added.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot 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 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 this complaint of patient complications and patient neurological deficit.

• Brand Name: TARGET 360 SOFT 3MM X 6CM
• 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: 17327960
• Report Number: 3008881809-2023-00352
• Device Sequence Number: 20497739
• Product Code: HCG
• UDI-Device Identifier: 04546540676429
• UDI-Public: 04546540676429
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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: 01/03/2026
• Device Model Number: M0035473060
• Device Catalogue Number: M0035473060
• Device Lot Number: 24090804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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: PIPELINE VANTAGE FLOW DIVERTING STENT (MEDTRONIC)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female