MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 1.5MM X 3.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	TG5411530
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Paresis (1998); Foreign Body In Patient (2687); Speech Disorder (4415); Ischemia Stroke (4418)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device remains implanted in the patient.
Event or Problem Description
It was reported the coil (subject device) was delivered and deployed through a microcatheter into the 1.6mm x 1.7mm pericollosal aneurysm.After the microcatheter was removed from the aneurysm, the physician did a contrast run and discovered that the coil (subject device) had dislodged out of the aneurysm and had migrated to one of the patient¿s two a3 branches.The physician spent several hours trying to access the distal branch with the goal of retrieving the dislodged coil (subject device) but was unable to access the a3 branch so the coil (subject device) could not be removed.The patient woke up aphasic and weak on the right side.No additional information available.
Event or Problem Description
It was reported the coil (subject device) was delivered and deployed through a microcatheter into the 1.6mm x 1.7mm pericollosal aneurysm.After the microcatheter was removed from the aneurysm, the physician did a contrast run and discovered that the coil (subject device) had dislodged out of the aneurysm and had migrated to one of the patient¿s two a3 branches.The physician spent several hours trying to access the distal branch with the goal of retrieving the dislodged coil (subject device) but was unable to access the a3 branch so the coil (subject device) could not be removed.The patient woke up aphasic and weak on the right side.No additional information available.Update: received additional information on 29-jun-2023 stated that medical intervention was performed as the physician tried for approximately four hours to retrieve the subject coil but the physician was unable to access the vessel where the subject coil was lodged.The patient suffered an ischemic stroke which resulted in patient hospitalization.The patient was beginning to speak again and was regaining some movement.No addiotnal information available.
Additional Manufacturer Narrative
B2 outcomes attributed to ae - updated, b5 executive summary - updated, f10 / h6 clinical signs code grid - health effect - clinical code - updated, f10 / h6 health impact code grid - health effect - impact code - updated.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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.
Event or Problem Description
It was reported the coil (subject device) was delivered and deployed through a microcatheter into the 1.6mm x 1.7mm pericollosal aneurysm.After the microcatheter was removed from the aneurysm, the physician did a contrast run and discovered that the coil (subject device) had dislodged out of the aneurysm and had migrated to one of the patient¿s two a3 branches.The physician spent several hours trying to access the distal branch with the goal of retrieving the dislodged coil (subject device) but was unable to access the a3 branch so the coil (subject device) could not be removed.The patient woke up aphasic and weak on the right side.No additional information available.Update: received additional information on 29-jun-2023 stated that medical intervention was performed as the physician tried for approximately four hours to retrieve the subject coil but the physician was unable to access the vessel where the subject coil was lodged.The patient suffered an ischemic stroke which resulted in patient hospitalization.The patient was beginning to speak again and was regaining some movement.No addiotnal information available.

• Brand Name: TARGET TETRA 1.5MM X 3.0CM
• 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: 17199812
• Report Number: 3008881809-2023-00316
• Device Sequence Number: 12147708
• Product Code: HCG
• UDI-Device Identifier: 07613327580105
• UDI-Public: 07613327580105
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K222533
• 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,Followup
• Report Date (Section B): 08/30/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2026
• Device Model Number: TG5411530
• Device Catalogue Number: TG5411530
• Device Lot Number: 24201887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 06/29/2023; 08/24/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 06/30/2023; 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• 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: SL-10 CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown