MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035476300
Medical Device Problem Codes	Expulsion (2933); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the anterior carotid aneurysm (aca) procedure, the operator used coils to fill the aneurysm.The operator placed the microcatheter and then inserted the subject coil.During subject coil adjustment in the aneurysm it fractured at the detachment point and part of it migrated into the parent vessel.The operator tried to use the guidewire to take the fragment out but could not.Then, the operator filled the rest of the coils and finished the procedure successfully.No clinical consequence's were reported to the patient due to this event.
Event or Problem Description
It was reported that during the anterior carotid aneurysm (aca) procedure, the operator used coils to fill the aneurysm.The operator placed the microcatheter and then inserted the subject coil.During subject coil adjustment in the aneurysm it fractured at the detachment point and part of it migrated into the parent vessel.The operator tried to use the guidewire to take the fragment out but could not.Then, the operator filled the rest of the coils and finished the procedure successfully.No clinical consequences were reported to the patient due to this event.Update: received additional information on 08-jan-2024 stated that the subject coil was prematurely detached during procedure which made part of the subject coil protruded out of the vessel (part of subject coil inside aneurysm and part inside vessel.) there was a surgical delay of 30 minutes.The patient current status is unknown.No additional information available.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.B5 executive summary - updated.F10 / h6 health impact code grid - health effect - impact code - updated.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not performed due to the device 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 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.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 and the device was not returned, an assignable cause of undeterminable was assigned to the reported events: ¿main coil prematurely detached/separated during use¿ and ¿main coil protrusion¿.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• 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: 18326688
• Report Number: 3008881809-2023-00582
• Device Sequence Number: 12642426
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: 04546540676559
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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: 03/05/2026
• Device Catalogue Number: M0035476300
• Device Lot Number: 24212055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2023
• 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: GUIDEWIRE (UNKNOWN); SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: Asian