MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035476300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the physician experienced resistance on an attempt to pull the coil (subject device) from the aneurysm when he didn't like the way the coil was deploying.The coil was not moving on further attempts of pulling indicating premature detachment of the coil.The physician used a snare device to remove the detached coil without disrupting the stents or the already implanted coil mass.The delivery wire of the coil was also damaged.The subject device was replaced, and the procedure was completed successfully with a delay of 60 minutes.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that the physician experienced resistance on an attempt to pull the coil (subject device) from the aneurysm when he didn't like the way the coil was deploying.The coil was not moving on further attempts of pulling indicating premature detachment of the coil.The physician used a snare device to remove the detached coil without disrupting the stents or the already implanted coil mass.The delivery wire of the coil was also damaged.The subject device was replaced, and the procedure was completed successfully with a delay of 60 minutes.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D9 - product available to stryker - updated d9 - returned to manufacturer on - updated h3 - device evaluated by mfg - updated due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was seen to be kinked/bent.The coil delivery wire proximal contact was seen to be kinked/bent.The main coil was seen to be stretched, kinked and broken/fractured.The main coil suture was broken.The introducer sheath was not returned.A functional test was unable to perform due to damage.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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that there was difficulty delivering the coil into the aneurysm and during removal, the coil appeared to detach.It was then removed using a retriever.Four coils had been deployed without issue prior to the event.The device was confirmed to be in good condition prior to use and it was transferred into the microcatheter without difficulty.The device appears to have been used per the dfu.The anatomy was noted to be very tortuous.Analysis of the returned device confirmed that the coil had not detached at the detachment zone but, rather the main coil had broken close to the main coil junction.Based on the review of all available information, an assignable cause of procedural factors will be assigned to the reported ¿main coil stretched¿, ¿device difficulty engaging target vessel¿ and to the as analysed ¿main coil kinked/bent¿, ¿main coil stretched¿, ¿main coil broken/fractured during use¿, ¿main coil suture damage¿.The issue is associated with a product that meets stryker design and manufacture specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of not confirmed will be assigned to the as reported ¿main coil prematurely detached/separated during use¿ as the coil had fractured rather than detached prematurely.An assignable cause of handling damage will be assigned to the reported ¿coil delivery wire damaged¿ and to the as analysed ¿coil delivery wire kinked/bent¿, ¿coil proximal contact kinked/bent¿.The issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• 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: 21858384
• Report Number: 3008881809-2025-00214
• Device Sequence Number: 7888850
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: (01)04546540676559(17)270429(10)24916514
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K242243
• 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): 07/08/2025

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: M0035476300
• Device Lot Number: 24916514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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 SL-10 MICROCATHETER (STRYKER).; NEUROFORM ATLAS STENT (STRYKER).; SOFIA 5F CATHETER (NON-STRYKER).; SOLITAIRE STENT (NON-STRYKER).; TARGET COIL (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male