MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 4MM X 12CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036124120
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the index procedure on (b)(6) 2024 was completed successfully as the subject coil was successfully delivered into the target aneurysm as intended.However, at the end of the procedure, the subject coil was popped out, therefore, the balloon was used to move the subject coil back into aneurysm.Then the stent was used to hold the subject coil in place.Per physician¿s opinion of the subject coil popped out was caused by oversizing of the subject coil.There were no clinical consequences reported due to the event.Post procedure target aneurysm status raymond score of 2 - residual neck/dog ear defined as the persistence of any portion of the original defect of the arterial wall.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes), 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 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.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.Based on the information provided the device was successfully delivered into the target aneurysm, as intended.There were no difficulties encountered during the applicable procedure that could have contributed to the reported event.In the physicians opinion the device performed as intended.The physician indicated that the coil protruded due to by oversizing of the coil.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.
Event or Problem Description
It was reported that the index procedure on (b)(6) 2024 was completed successfully as the subject coil was successfully delivered into the target aneurysm as intended.However, at the end of the procedure, the subject coil was popped out, therefore, the balloon was used to move the subject coil back into aneurysm.Then the stent was used to hold the subject coil in place.Per physician¿s opinion of the subject coil popped out was caused by oversizing of the subject coil.There were no clinical consequences reported due to the event.Post procedure target aneurysm status raymond score of 2 - residual neck/dog ear defined as the persistence of any portion of the original defect of the arterial wall.

• Brand Name: TARGET XL 360 SOFT 4MM X 12CM
• 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: 21253769
• Report Number: 3008881809-2025-00058
• Device Sequence Number: 18407022
• Product Code: HCG
• UDI-Device Identifier: 07613327128338
• UDI-Public: (01)07613327128338(17)270501(10)24913901
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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 Catalogue Number: M0036124120
• Device Lot Number: 24913901
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• 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: EXCELSIOR 1018 MICROCATHETER (STRYKER); NEUROFORM ATLAS STENT (STRYKER); SCEPTER XC BALLOON DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 61 KG