MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection of the returned subject device revealed that the main coil was the only part of the device returned.The main coil was seen to be kinked bent and stretched.The main coil was detached from the pusher wire.A functional test could not be performed due to the condition of the returned 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, and the patient's anatomy was not tortuous.The main coil was seen to be kinked bent, stretched and was detached.The as analysed defects are indicative of the as reported complaint and therefore, the as reported complaint can be confirmed based on analysis.The as reported as well as the as analysed listed in the grid below will be assigned procedural factors as it 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 initially reported during mca (middle cerebral artery) aneurysm procedure, the coil (subject device) experience resistance when advancing into the microcatheter tip.The operator used another coil to complete the procedure without clinical consequences to the patient.Analysis of the returned device revealed that the subject coil was prematurely detached/separated during use.There was no clinical consequence to the patient due to this event.

• Brand Name: TARGET 360 NANO 1MM X 3CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11844816
• Report Number: 3008881809-2021-00210
• Device Sequence Number: 14308970
• Product Code: HCG
• UDI-Device Identifier: 04546540697974
• UDI-Public: 04546540697974
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153658
• 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
• Report Date (Section B): 05/18/2021

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 Expiration Date: 11/13/2022
• Device Model Number: M0035421030
• Device Catalogue Number: M0035421030
• Device Lot Number: 21925222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 58