MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035442540
Medical Device Problem Codes	Fracture (1260); Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an anterior communicating artery (acom artery) ruptured aneurysm case after deployment of the subject coil the physician was withdrawing the microcatheter and the proximal end part of the coil fractured and deviated from the aneurysm.A snare device was used to remove the coil.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
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 and microscopic inspection, it was observed that two pieces of the cut microcatheter were returned with the main coil detached.There was a snare device found inserted in the cut microcatheter.The coil delivery wire was not returned.The main coil was seen kinked/bent and found to be stretched.Functional inspection was not required as the returned coil wasn¿t broken.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 event was confirmed during device analysis as the device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.However, the main coil was not fractured, and the entire coil was returned.It was reported that after deployment of the coil, while pulling back the microcatheter, the coil was jammed in the tip of the microcatheter and pulled out of the coil mass.A snare had to be used to retrieve the coil from the patient.The physician perceived the coil to have fractured but based on the returned device inspection it was confirmed that the coil had not broken but was damaged.An assignable cause of not confirmed will be assigned to the as reported 'main coil broken/fractured during use'.An assignable cause of procedural factors will be assigned to the as reported 'coil in catheter friction', 'coil jammed', 'main coil protrusion' and the as analyzed 'main coil kinked/bent', 'main coil stretched' as 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
It was reported that during an anterior communicating artery (acom artery) ruptured aneurysm case after deployment of the subject coil the physician was withdrawing the microcatheter and the proximal end part of the coil fractured and deviated from the aneurysm.A snare device was used to remove the coil.The procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 2.5MM X 4CM
• 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: 20965055
• Report Number: 3008881809-2024-00609
• Device Sequence Number: 15548267
• Product Code: HCG
• UDI-Device Identifier: 07613252600305
• UDI-Public: (01)07613252600305(17)270206(10)24717791
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113412
• 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): 02/24/2025

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 Catalogue Number: M0035442540
• Device Lot Number: 24717791
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER).; GUIDEWIRE (UNKNOWN).; SNARE (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose