MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036181450
Medical Device Problem Codes	Expulsion (2933); Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during an intrinsic hepatic artery aneurysm case, resistance was encountered while advancing subject coil in the shaft of microcatheter.The subject coil encountered difficulty in engaging with the stent and vessel wall during repositioning, leading to the premature detachment from the coil junction within the vessel.A gooseneck snare was used to retrieve the fractured coil, but retrieval was unsuccessful, so the fractured coil was left in the patient.Surgical delay of 300 minutes was observed, and patient is under observation.Additional embolization of the aneurysm is expected to be performed.
Event or Problem Description
It was reported during an intrinsic hepatic artery aneurysm case, resistance was encountered while advancing subject coil in the shaft of microcatheter.The subject coil encountered difficulty in engaging with the stent and vessel wall during repositioning, leading to the premature detachment from the coil junction within the vessel.A gooseneck snare was used to retrieve the fractured coil, but retrieval was unsuccessful, so the fractured coil was left in the patient.Surgical delay of 300 minutes was observed, and patient is under observation.Additional embolization of the aneurysm is expected to be performed.
Additional Manufacturer Narrative
F10 / h6 device code grid - corrected.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 coil was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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 indicated that the device was confirmed to be in good condition prior to use.Continuous flush was not maintained which may have contributed to the reported friction.The anatomy was also noted to be severely tortuous.An assignable cause of undeterminable will be assigned to this complaint as the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.

• Brand Name: TARGET XXL 360 14MM 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: 20901876
• Report Number: 3008881809-2024-00591
• Device Sequence Number: 9053361
• Product Code: HCG
• UDI-Device Identifier: 07613327128383
• UDI-Public: (01)07613327128383(17)251023(10)23978324
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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 Expiration Date: 10/23/2025
• Device Catalogue Number: M0036181450
• Device Lot Number: 23978324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2022
• 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: EXCELSIOR 1018 MICROCATHETER (STRYKER).; SNARE (UNKNOWN).; TARGET 360 XXL COIL (STRYKER).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown