MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036128300
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer, as device is implanted in patient.
Event or Problem Description
It was reported that during a cerebral aneurysm coiling embolization procedure, the subject coil was unraveled midway through deployment in the aneurysm.The neuro-interventionalist did unsuccessful attempt to remove the defective unraveled subject coil using multiple devices without disrupting the partially deployed coil within the aneurysm.The stent was deployed to secure the tail of the subject coil protruding out of aneurysm against the wall of the native vessel.No other information is available.
Additional Manufacturer Narrative
Expiration date - added.Manufacturing date ¿ added.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 physical analysis 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 during a cerebral aneurysm coiling embolization procedure, the subject coil unraveled midway through deployment in the aneurysm.The neuro-interventionalist tried to remove the defective coil using multiple devices, but after several unsuccessful attempts the choice was made to deploy a stent to secure the tail of the subject coil against the native vessel wall.No further details of the procedure were provided.While there are a number of potential causes for the reported issue of main coil protrusion and main coil stretched, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during a cerebral aneurysm coiling embolization procedure, the subject coil was unraveled midway through deployment in the aneurysm.The neuro-interventionalist did unsuccessful attempt to remove the defective unraveled subject coil using multiple devices without disrupting the partially deployed coil within the aneurysm.The stent was deployed to secure the tail of the subject coil protruding out of aneurysm against the wall of the native vessel.No other information is available.

• Brand Name: TARGET XL 360 SOFT 8MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11516529
• Report Number: 3008881809-2021-00129
• Device Sequence Number: 11723626
• Product Code: HCG
• UDI-Device Identifier: 07613327004649
• UDI-Public: 07613327004649
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2022
• Device Model Number: M0036128300
• Device Catalogue Number: M0036128300
• Device Lot Number: 21845646
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention