MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036121240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a posterior arteriovenous fistula (avf) case, resistance was felt during advancement, and subject coil was stretched and prematurely detached during use.Attempts were made to retrieve the remaining coil; however, it could not be retrieved.The procedure was completed as it was, and the patient condition is not known.
Additional Manufacturer Narrative
G4 pma/510(k - 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.It was reported that the coil stretched and detached prematurely during implantation.The doctor's opinion was that it could not be coiled in the aneurysm and stretched because he attempted to implant a 12 mm coil in a 6 mm diameter vessel.There is insufficient evidence available to determine if this was the cause for the reported events.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.
Event or Problem Description
It was reported that during a posterior arteriovenous fistula (avf) case, resistance was felt during advancement, and subject coil was stretched and prematurely detached during use.Attempts were made to retrieve the remaining coil; however, it could not be retrieved.The procedure was completed as it was, and the patient condition is not known.

• Brand Name: TARGET XL 360 SOFT 12MM X 45CM
• 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: 21074167
• Report Number: 3008881809-2025-00010
• Device Sequence Number: 8444348
• Product Code: HCG
• UDI-Device Identifier: 04546540711533
• UDI-Public: (01)04546540711533(17)270106(10)24697870
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K242243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: M0036121240
• Device Lot Number: 24697870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2024
• 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: CARRY UX19 MICROCATHETER (UTM)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female