MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 18MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036101850
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a cerebral aneurysm embolization procedure, the subject coil was unable to position firmly at the treatment site.As the subject coil was being retracted from the catheter, it prematurely detached.The entire catheter was withdrawn from the patient with the subject coil.The subject coil was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H3 other text : device not returned for evaluation.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and 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.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.Additional information provided by the customer that the coil was repositioned several times to engage with the aneurysm.Then the subject coil was pulled back, and it got unexpected prematurely detached inside of the microcatheter.This may have occurred due to manipulation or procedural factors.However, it cannot be confirmed as the device was not returned.While there are a number of potential causes for the reported issue of device difficulty engaging target vessel and main coil prematurely detached/separated during use, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to this complaint.
Event or Problem Description
It was reported during a cerebral aneurysm embolization procedure, the subject coil was unable to position firmly at the treatment site.As the subject coil was being retracted from the catheter, it prematurely detached.The entire catheter was withdrawn from the patient with the subject coil.The subject coil was replaced and the procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: TARGET XL 360 STANDARD 18MM X 50CM
• 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: 18997245
• Report Number: 3008881809-2024-00129
• Device Sequence Number: 11477650
• Product Code: HCG
• UDI-Device Identifier: 07613327004724
• UDI-Public: 07613327004724
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2025
• Device Catalogue Number: M0036101850
• Device Lot Number: 23529449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• 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: CATHETER (UNKNOWN)
• Patient Age: 81 YR
• Patient Sex: Female