MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 7MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035477300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an aneurysm procedure, the physician used the subject coil to embolize the aneurysm.After part of the subject coil was pushed into the aneurysm sac, the physician deemed the position of the framing coil within the sac unsatisfactory and intended to adjust the angle.While withdrawing the subject coil, the connection between the subject coil and the delivery wire ruptured, causing the delivery wire to separate from the subject coil, with only the anti-stretch wire remaining connected.The physician slowly retracted the subject coil, with part of it retracting into the microcatheter and part remaining in the blood vessel and aneurysm.Therefore, the physician carefully withdrew the microcatheter to bring the ruptured subject coil out of the body.When pulling the coil out to the rhv position, the anti-stretch wire connecting the subject coil and the delivery wire completely ruptured.A new coil was replaced, and the surgery was completed without any clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.D4 gtin - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H4 manufacturing date ¿ added.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 main coil was seen to be fractured, stretched, tangled and kinked.The main coil suture was seen to be damaged.The coil delivery wire and introducer sheath were not returned.There were no visual defects confirmed during the functional inspection.The reported complaint was confirmed based on device analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.It was reported that while withdrawing the coil for repositioning, the main coil ruptured causing the coil to separate from the delivery wire.The coil was removed and replaced with another of the same model and the case was completed successfully.Additional information provided by the customer indicated that the device was in good condition prior to use and there is no indication of a use error.The device was returned for analysis, and it was noted that main coil was fractured.The proximal coil or delivery wire were not returned.The main coil was also noted to be kinked, stretched and the suture was broken.An assignable cause of procedural factors will be assigned to all as reported and as analyzed ar/aa main coil broken/fractured during use and to as analyzed main coil kinked/bent, main coil tangled, main coil stretched and main coil suture damage.This complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
During an aneurysm procedure, the physician used the subject coil to embolize the aneurysm.After part of the subject coil was pushed into the aneurysm sac, the physician deemed the position of the framing coil within the sac unsatisfactory and intended to adjust the angle.While withdrawing the subject coil, the connection between the subject coil and the delivery wire ruptured, causing the delivery wire to separate from the subject coil, with only the anti-stretch wire remaining connected.The physician slowly retracted the subject coil, with part of it retracting into the microcatheter and part remaining in the blood vessel and aneurysm.Therefore, the physician carefully withdrew the microcatheter to bring the ruptured subject coil out of the body.When pulling the coil out to the rhv position, the anti-stretch wire connecting the subject coil and the delivery wire completely ruptured.A new coil was replaced, and the surgery was completed without any clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 7MM 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: 23372649
• Report Number: 3008881809-2025-00578
• Device Sequence Number: 10122683
• Product Code: HCG
• UDI-Device Identifier: 04546540676580
• UDI-Public: (01)04546540676580(17)291231(10)25378900
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/11/2025

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 Catalogue Number: M0035477300
• Device Lot Number: 25378900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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
• Patient Sex: Unknown