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

Model Number M0035475150

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

Patient Problems Visual Impairment (2138); Cognitive Changes (2551)

Event Date 12/10/2021

Event Type  Injury  

Manufacturer Narrative

9 of 9 reports.Device is implanted in patient.

Event Description

It was reported in a clinical trial procedure to treat a right posterior communicating artery aneurysm, the patient had hemianopia and delirium.On imaging, occipital micro embolic infarcts were seen which resulted in prolonged hospitalization for the patient.The event was treated with physiotherapy and oral olanzapin 5 mg for delirium for 5 days and recovered.In the physician's opinion, the event was possibly related to the subject device and other stryker devices used in the procedure.

Event Description

It was reported in a clinical trial procedure to treat a right posterior communicating artery aneurysm, the patient had hemianopia and delirium.On imaging, occipital micro embolic infarcts were seen which resulted in prolonged hospitalization for the patient.The event was treated with physiotherapy and oral olanzapin 5 mg for delirium for 5 days and recovered.In the physician's opinion, the event was possibly related to the subject device and other stryker devices used in the procedure.

Manufacturer Narrative

Due to the automated mes system 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.It was reported that in a clinical trial, the patient had hemianopia and delirium post procedure with the subject coil.The ae was treated with physiotherapy and oral olanzapin 5 mg for delirium for 5 days.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.

• Brand Name: TARGET 360 SOFT 5MM X 15CM
• 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: 13262428
• MDR Text Key: 283951798
• Report Number: 3008881809-2022-00021
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540676504
• UDI-Public: 04546540676504
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0035475150
• Device Catalogue Number: M0035475150
• Device Lot Number: 23072068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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 XT27 1 TIP STRAIGHT 150CM X 6CM; SL-10 2 TIP STRAIGHT 150CM X 6CM; SURPASS EVOLVE 4.5MM X 17MM - IDE; SYNCHRO 0.014IN X 200CM; SYNCHRO 0.014IN X 300CM; TARGET 360 SOFT 6MM X 20CM; TARGET 360 STANDARD 6MM X 15CM; TARGET 360 STANDARD 7MM X 20CM
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Female