MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035424150
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported during the procedure to treat a right ica-oa (internal carotid artery) bifuration aneurysm, when half of the subject coil was placed in the aneurysm, the other half stretched and protruded out of the aneurysm.The physician used a stent device as a snare to press the stretched coil in the vessel.The remaining part of the stretched coil was left inside of the patient¿s vessel from the intracranial position to the puncture site.After it was taken out, the physician cut the remaining stretched segment at the puncture point.No other information is available.
Event or Problem Description
It was reported during the procedure to treat a right ica-oa (internal carotid artery) bifuration aneurysm, when half of the subject coil was placed in the aneurysm, the other half stretched and protruded out of the aneurysm.The physician used a stent device as a snare to press the stretched coil in the vessel.The remaining part of the stretched coil was left inside of the patient¿s vessel from the intracranial position to the puncture site.After it was taken out, the physician cut the remaining stretched segment at the puncture point.No other information is available.
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 the visual inspection, the main coil was found to be broken/fractured and severely stretched.The coil delivery wire and introducer sheath were not returned.Functional inspection, main coil protrusion functional test - n/a.Main coil stretched functional test - n/a.Confirmed during visual inspection.Un-retrieved device fragments functional test - n/a.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 main coil stretched was confirmed during the analysis.The reported main coil protrusion could not be confirmed; however, the analysis results are consistent with the reported event.The reported un-retrieved device fragments 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 device was analyzed.The main coil was found to be severely stretched and broken/fractured.The coil delivery wire was not returned.An assignable cause of procedural factors will be assigned to the ar codes- main coil stretched, main coil protrusion, un-retrieved device fragments and aa codes main coil stretched, main coil broken/fractured during use as these defects appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• Brand Name: TARGET 360 ULTRA 4MM X 15CM
• 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: 16504134
• Report Number: 3008881809-2023-00111
• Device Sequence Number: 12304166
• Product Code: HCG
• UDI-Device Identifier: 04546540675941
• UDI-Public: 04546540675941
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023

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 Expiration Date: 02/01/2025
• Device Model Number: M0035424150
• Device Catalogue Number: M0035424150
• Device Lot Number: 23451549
• 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: 02/14/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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 MIDDLE CATHETER (WALLABY); 8F GUIDE CATHETER (MEDTRONIC); NAVION-072 CATHETER (MEDTRONIC); NEUROFORM EZ STENT (STRYKER); REBAR-027 MICROCATHETER (MEDTRONIC); SOLITAIRE STENT (MEDTRONIC); SYNCHRO GUIDEWIRE (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Race: Asian