MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035443060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the process of endovascular coiling of a.Com aneurysm while the coil (subject device) introduced inside aneurysm it detached spontaneously and elongated inside micro catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.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 coil was inspected prior to use and no anomalies were noted, the device was prepared as per the dfu, continuous flush was maintained for the duration of the procedure, and the coil was not advanced or retracted with force.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.
Event or Problem Description
It was reported that during the process of endovascular coiling of a.Com aneurysm while the coil (subject device) introduced inside aneurysm it detached spontaneously and elongated inside micro catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was found to be severely kinked/bent, the coil delivery wire was found to be broken/fractured, the main coil was not returned, and the introducer sheath was found to be intact.A functional inspection was not required.The reported 'main coil prematurely detached/separated during use' could not be confirmed; however, the analysis results are consistent with the reported event.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.Additional information provided by the customer indicated that the coil was inspected prior to use and no anomalies were noted, the device was prepared as per the dfu, continuous flush was maintained for the duration of the procedure, and the coil was not advanced or retracted with force.During analysis, the coil delivery wire was found to be severely kinked/bent and broken/fractured.The main coil was not returned and it could not be definitively determined whether the coil had prematurely detached mechanically from the delivery wire or electrolytically from the inzone.Therefore, the as reported 'main coil prematurely detached/separated' was not confirmed.It is probable that the coil delivery wire was damaged due to handling during the procedure.Therefore, an assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire broken/fractured during use' and ¿coil delivery wire kinked/bent'.
Event or Problem Description
It was reported that during the process of endovascular coiling of a.Com aneurysm while the coil (subject device) introduced inside aneurysm it detached spontaneously and elongated inside micro catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 NANO 3MM X 6CM
• 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: 12866778
• Report Number: 3008881809-2021-00487
• Device Sequence Number: 3459055
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: 07613252600329
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2022

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: 04/10/2024
• Device Model Number: M0035443060
• Device Catalogue Number: M0035443060
• Device Lot Number: 22847479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 02/01/2022; 03/02/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 02/07/2022; 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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: 6F (STRYKER MANUFACTURER); SL 10 (STRYKER MANUFACTURER)
• Patient Sex: Male