MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 9MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0035469300

Device Problem Premature Separation (4045)

Patient Problems Foreign Body In Patient (2687); Cerebral Edema (4403); Thrombosis/Thrombus (4440)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

Device not returned for evaluation.

Event Description

It was reported that during the procedure to treat subarachnoid hemorrhage, the coil (subject device) got stretched and detached prematurely at the aorta artery.The physician attempted to remove the coil with a snare device, but was unsuccessful.It was reported that the patient passed away after the procedure due to brain swelling caused by thrombogenic progression and spasm developed due to the preexisting subarachnoid hemorrhage.

Event Description

It was reported that during the procedure to treat subarachnoid hemorrhage, the coil (subject device) got stretched and detached prematurely at the aorta artery.The physician attempted to remove the coil with a snare device, but was unsuccessful.It was reported that the patient passed away after the procedure due to brain swelling caused by thrombogenic progression and spasm developed due to the preexisting subarachnoid hemorrhage.

Manufacturer Narrative

H4 manufacturing date: added.D4 expiration date: added.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.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.Additional information provided by the customer indicated that the patient had subarachnoid hemorrhage (sah) before starting the procedure, and the blood vessels had a lot of thrombogenic progression and spasm.The patient's blood vessels were very long and tortuous.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the as reported.H3 other text : device not returned for evaluation.

• Brand Name: TARGET 360 STANDARD 9MM X 30CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10767041
• MDR Text Key: 214112070
• Report Number: 3008881809-2020-00321
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540676351
• UDI-Public: 04546540676351
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2022
• Device Model Number: M0035469300
• Device Catalogue Number: M0035469300
• Device Lot Number: 22061691
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SL-10 CATHETER (STRYKER).
• Patient Outcome(s): Death; Required Intervention