MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 6MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035466150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	Paresis (1998); Obstruction/Occlusion (2422)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during an endovascular treatment of giant right internal carotid artery aneurysm, when the subject coil was withdrawn to re-position due to unsatisfactory positioning the 1st few millimeters of the subject coil came out and the subject coil spontaneously detached.It was reported that the subject coil occluded the impinged vessel.A stent was deployed to reopen the occluded vessel.Antiplatelets were administered to the patient.It was noted that the procedure time was prolonged by two hours and 48 hours post procedure patient developed fluctuating left sided weakness.
Additional Manufacturer Narrative
Due to the automated mes 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 kinked/bent in multiple areas.The main coil was found to be detached/separated.The detachment seems to be mechanical.The main coil was not returned.The coil introducer sheath was found to be intact.Functional inspection was not required as the reported premature detachment of the main coil was confirmed during visual inspection.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 of main coil prematurely detached/separated during use was confirmed during the analysis.The reported patient vessel occlusion and patient neurological deficit could not be confirmed during the analysis as the issues are patient/procedure related.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 detached/separated from the coil delivery wire and not returned.The coil delivery was found to be kinked/bent.An assignable cause of procedural factors will be assigned to the as reported and as analyzed event 'main coil prematurely detached/separated during use', and to the as reported events 'patient vessel occlusion' and 'patient neurological deficit' 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.An assignable cause of handling damage was assigned to the as analyzed event 'coil delivery wire kinked/bent' as the defect appears to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
It was reported that during an endovascular treatment of giant right internal carotid artery aneurysm, when the subject coil was withdrawn to re-position due to unsatisfactory positioning the 1st few millimeters of the subject coil came out and the subject coil spontaneously detached.It was reported that the subject coil occluded the impinged vessel.A stent was deployed to reopen the occluded vessel.Antiplatelets were administered to the patient.It was noted that the procedure time was prolonged by two hours and 48 hours post procedure patient developed fluctuating left sided weakness.
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 kinked/bent in multiple areas.The main coil was found to be detached/separated.The detachment seems to be mechanical.The main coil was not returned.The coil introducer sheath was found to be intact.Functional inspection was not required as the reported premature detachment of the main coil was confirmed during visual inspection.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 of main coil prematurely detached/separated during use was confirmed during the analysis.The reported patient vessel occlusion and patient neurological deficit could not be confirmed during the analysis as the issues are patient/procedure related.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 detached/separated from the coil delivery wire and not returned.The coil delivery was found to be kinked/bent.The device was sent for additional testing as per customer request.The sem (scanning electron microscopy) test was performed and the results are consistent with the analysis findings.It was confirmed that the detachment of the coil was mechanical.The results show evidence of torsional stresses, which is caused by twisting/rotating action applied to the device and ductile failure, which is caused by significant stress (which exceeds material strength) applied to the device.As per dfu the rotation of the delivery wire may result in premature detachment " do not rotate delivery wire during or after delivery of the coil.Rotating the target detachable coil delivery wire may result in a stretched coil or premature detachment of the coil from the delivery wire, which could result in coil migration".These results indicate that there was a significant friction/resistance during advancement/withdrawing of the coil during the procedure that could cause damages to the device and reported events.An assignable cause of procedural factors will be assigned to the as reported and as analyzed event 'main coil prematurely detached/separated during use', and to the as reported events 'patient vessel occlusion' and 'patient neurological deficit' 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.An assignable cause of handling damage was assigned to the as analyzed event 'coil delivery wire kinked/bent' as the defect appears to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
It was reported that during an endovascular treatment of giant right internal carotid artery aneurysm, when the subject coil was withdrawn to re-position due to unsatisfactory positioning the 1st few millimeters of the subject coil came out and the subject coil spontaneously detached.It was reported that the subject coil occluded the impinged vessel.A stent was deployed to reopen the occluded vessel.Antiplatelets were administered to the patient.It was noted that the procedure time was prolonged by two hours and 48 hours post procedure patient developed fluctuating left sided weakness.

• Brand Name: TARGET 360 STANDARD 6MM 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: 16603679
• Report Number: 3008881809-2023-00151
• Device Sequence Number: 6093839
• Product Code: HCG
• UDI-Device Identifier: 04546540676269
• UDI-Public: 04546540676269
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup,Followup
• Report Date (Section B): 10/31/2023

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: 11/28/2025
• Device Model Number: M0035466150
• Device Catalogue Number: M0035466150
• Device Lot Number: 24028583
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 04/11/2023; 10/11/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 05/03/2023; 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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: BENCHMARK GUIDER (UNKNOWN).; EXCELSIOR SL-10 MIRCROCATHETER (STRYKER).; NEUROFORM ATLAS STENT (STRYKER).
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male