MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036121240
Medical Device Problem Codes	Fracture (1260); Expulsion (2933)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post two atlas stent placements in a y configuration (one from l aca ¿anterior cerebral artery¿ to ica ¿internal carotid artery¿ and one from l mca ¿middle cerebral artery¿ to ica ¿internal carotid artery¿), doctor began coiling the aneurysm through a jailed sl-10 45 microcatheter.During his fourth coil deployment, when the doctor was trying to reposition the coil (subject device) it got stuck and wouldn¿t advance into the aneurysm or pull back out of the aneurysm.The doctor assumed at this point that the coil (subject device) fractured and broke.The coil (subject device) was partially in the aneurysm and partially out of the aneurysm.The coil (subject device) was never attempted to be detached.At the same time, there was thrombus formation.Used goose neck snare as medical intervention to retrieve any portion of the coil (subject device) but it was unsuccessful.No one was able to identify exactly where the coil (subject device) break occurred.Third atlas stent was then placed proximal to the y stents in the (ica) internal carotid artery to tack the coil (subject device) tail against the (ica) internal carotid artery vessel wall as medical intervention.Additionally, because it is believed that the primary wire stretched and unraveled more proximally, two (non- stryker) abbot xact carotid stents were subsequently placed to further tack the unraveled coil (subject device) against the vessel wall as medical intervention.The first (non- stryker) stent was placed from the proximal left (ica) internal carotid artery into the common carotid artery (cca) and the second (non -stryker) stent was placed even more proximally in the common carotid artery (cca).Prior to the second (non -stryker) stent being placed, doctor was able to successfully push additional clumps of unraveled coil into the origin of the external carotid artery.The primary wire coil (subject device) was all clumped together, it was viewed in the patient¿s descending aorta upon completion of the case.The team of physicians determined that the primary wire would be too small to successfully snare from the patient¿s aorta.It was left in the patient.There was surgical delay for an estimated 3 hours due to the coil (subject device) fracture.The patient remained intubated upon procedure completion.Six hours post procedure the patient was following command.The procedure was completed successfully.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that post two atlas stent placements in a y configuration (one from l aca ¿anterior cerebral artery¿ to ica ¿internal carotid artery¿ and one from l mca ¿middle cerebral artery¿ to ica ¿internal carotid artery¿), doctor began coiling the aneurysm through a jailed sl-10 45 microcatheter.During his fourth coil deployment, when the doctor was trying to reposition the coil (subject device) it got stuck and wouldn¿t advance into the aneurysm or pull back out of the aneurysm.The doctor assumed at this point that the coil (subject device) fractured and broke.The coil (subject device) was partially in the aneurysm and partially out of the aneurysm.The coil (subject device) was never attempted to be detached.At the same time, there was thrombus formation.Used goose neck snare as medical intervention to retrieve any portion of the coil (subject device) but it was unsuccessful.No one was able to identify exactly where the coil (subject device) break occurred.Third atlas stent was then placed proximal to the y stents in the (ica) internal carotid artery to tack the coil (subject device) tail against the (ica) internal carotid artery vessel wall as medical intervention.Additionally, because it is believed that the primary wire stretched and unraveled more proximally, two (non- stryker) abbot xact carotid stents were subsequently placed to further tack the unraveled coil (subject device) against the vessel wall as medical intervention.The first (non- stryker) stent was placed from the proximal left (ica) internal carotid artery into the common carotid artery (cca) and the second (non -stryker) stent was placed even more proximally in the common carotid artery (cca).Prior to the second (non -stryker) stent being placed, doctor was able to successfully push additional clumps of unraveled coil into the origin of the external carotid artery.The primary wire coil (subject device) was all clumped together, it was viewed in the patient¿s descending aorta upon completion of the case.The team of physicians determined that the primary wire would be too small to successfully snare from the patient¿s aorta.It was left in the patient.There was surgical delay for an estimated 3 hours due to the coil (subject device) fracture.The patient remained intubated upon procedure completion.Six hours post procedure the patient was following command.The procedure was completed successfully.
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 a visual inspection, the device was returned together with an unknown/non-stryker microcatheter and snare device, and with sl-10 (cut during the procedure by the physician.Cut further during the analysis to remove the coil and broken parts of the coil delivery wire), the main coil was found to be broken/fractured, the main coil was found to be severely stretched, the main coil was found to be tangled, the coil delivery wire was found to be broken/fractured 126 cm from the proximal end, the broken off fragment of the coil delivery wire was removed from the catheter.The fragment was cut during the analysis (no code will be used for coil delivery wire fracture as the catheter was cut by the physician during the procedure).A functional test for main coil broken/fractured during use, main coil stretched, un-retrieved device fragments, and main coil tangled was not performed.The defect was confirmed during visual inspection.A functional test for main coil protrusion, device difficulty engaging target vessel, and patient vessel thrombosis was not available.The reported main coil broken/fractured during use was confirmed during the analysis.The reported un-retrieved device fragments was confirmed during the analysis.The reported main coil stretched was confirmed during the analysis.The reported main coil tangled was confirmed during the analysis.The reported device difficulty engaging target vessel, main coil protrusion, and patient vessel thrombosis could not be confirmed during the analysis as the events 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 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 device was returned together with unknown/non-stryker microcatheter and snare device, and with sl-10 (cut during the procedure by the physician.Cut further during the analysis to remove the coil and broken parts of the coil delivery wire).During analysis, the main coil was found to be broken/fractured, severely stretched and tangled.An assignable cause of procedural factors will be assigned to the as reported and as analyzed issue codes ¿main coil broken/fractured during use¿, ¿un-retrieved device fragments¿, ¿main coil stretched¿ and ¿main coil tangled¿ since these issues are 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 and/or anatomical factors during use.An assignable cause of 'not confirmed' was assigned to the reported defect ¿device difficulty engaging target vessel¿, ¿main coil protrusion¿, and ¿patient vessel thrombosis¿ as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.
Event or Problem Description
It was reported that post two atlas stent placements in a y configuration (one from l aca ¿anterior cerebral artery¿ to ica ¿internal carotid artery¿ and one from l mca ¿middle cerebral artery¿ to ica ¿internal carotid artery¿), doctor began coiling the aneurysm through a jailed sl-10 45 microcatheter.During his fourth coil deployment, when the doctor was trying to reposition the coil (subject device) it got stuck and wouldn¿t advance into the aneurysm or pull back out of the aneurysm.The doctor assumed at this point that the coil (subject device) fractured and broke.The coil (subject device) was partially in the aneurysm and partially out of the aneurysm.The coil (subject device) was never attempted to be detached.At the same time, there was thrombus formation.Used goose neck snare as medical intervention to retrieve any portion of the coil (subject device) but it was unsuccessful.No one was able to identify exactly where the coil (subject device) break occurred.Third atlas stent was then placed proximal to the y stents in the (ica) internal carotid artery to tack the coil (subject device) tail against the (ica) internal carotid artery vessel wall as medical intervention.Additionally, because it is believed that the primary wire stretched and unraveled more proximally, two (non- stryker) abbot xact carotid stents were subsequently placed to further tack the unraveled coil (subject device) against the vessel wall as medical intervention.The first (non- stryker) stent was placed from the proximal left (ica) internal carotid artery into the common carotid artery (cca) and the second (non -stryker) stent was placed even more proximally in the common carotid artery (cca).Prior to the second (non -stryker) stent being placed, doctor was able to successfully push additional clumps of unraveled coil into the origin of the external carotid artery.The primary wire coil (subject device) was all clumped together, it was viewed in the patient¿s descending aorta upon completion of the case.The team of physicians determined that the primary wire would be too small to successfully snare from the patient¿s aorta.It was left in the patient.There was surgical delay for an estimated 3 hours due to the coil (subject device) fracture.The patient remained intubated upon procedure completion.Six hours post procedure the patient was following command.The procedure was completed successfully.

• Brand Name: TARGET XL 360 SOFT 12MM X 45CM
• 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: 13579050
• Report Number: 3008881809-2022-00077
• Device Sequence Number: 19925694
• Product Code: HCG
• UDI-Device Identifier: 04546540711533
• UDI-Public: 04546540711533
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/02/2022

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: 05/24/2024
• Device Model Number: M0036121240
• Device Catalogue Number: M0036121240
• Device Lot Number: 22923019
• 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: 02/03/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• 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: EXCELSIOR SL-10 CATHETER (STRYKER MANUFACTURER).; SEVEN TARGET XL 360 COILS (STRYKER MANUFACTURER).; THREE ATLAS STENT (STRYKER MANUFACTURER).; TWO XACT CAROTID STENTS (ABBOTT MANUFACTURER).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Female