MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035425150
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer as the fractured portioned of the subject device was left inside the patient's vasculature.
Event or Problem Description
It was reported that a stent assisted coiling procedure was performed in a patient with left ica ( internal carotid artery) c5 (segment) aneurysm.During the procedure, when the physician insert the subject coil into the aneurysm, after half of the subject coil was filled into the aneurysm, a fractured loop of the subject coil dropped out of the aneurysm.So the physician deployed a stent to support and continued to fill the subject coil.Later when the physician attempted to detach the subject coil using a power supply system, he found that the subject coil was not detached.The physician replaced the power supply system for three times to detach the subject coil but was still not able to detach the subject coil.Therefore the physician decided to retrieve the subject coil and found that the subject coil was fractured and the fractured part of the subject coil remained inside the patients vascular anatomy.The physician used a guidewire to push the fractured subject coil back into the aneurysm, during this adjustment, the tip of the microcatheter migrated out of the aneurysm and the fracture subject coil was taken to the vessel as well.The physician deployed another stent to press the fractured subject coil against the vessel wall.The subject coil was replaced and the physician continued to fill the aneurysm.The procedure was completed successfully.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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 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 device was not returned and therefore the as reported cannot be confirmed.The as reported 'main coil broken/fractured during use', 'main coil migration', 'main coil failed/unable to detach', 'un-retrieved device fragments' will be assigned undeterminable.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, a cause of undeterminable was assigned.
Event or Problem Description
It was reported that a stent assisted coiling procedure was performed in a patient with left ica ( internal carotid artery) c5 (segment) aneurysm.During the procedure, when the physician insert the subject coil into the aneurysm, after half of the subject coil was filled into the aneurysm, a fractured loop of the subject coil dropped out of the aneurysm.So the physician deployed a stent to support and continued to fill the subject coil.Later when the physician attempted to detach the subject coil using a power supply system, he found that the subject coil was not detached.The physician replaced the power supply system for three times to detach the subject coil but was still not able to detach the subject coil.Therefore the physician decided to retrieve the subject coil and found that the subject coil was fractured and the fractured part of the subject coil remained inside the patients vascular anatomy.The physician used a guidewire to push the fractured subject coil back into the aneurysm, during this adjustment, the tip of the microcatheter migrated out of the aneurysm and the fracture subject coil was taken to the vessel as well.The physician deployed another stent to press the fractured subject coil against the vessel wall.The subject coil was replaced and the physician continued to fill the aneurysm.The procedure was completed successfully.

• Brand Name: TARGET 360 ULTRA 5MM 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: 14139703
• Report Number: 3008881809-2022-00181
• Device Sequence Number: 6371890
• Product Code: HCG
• UDI-Device Identifier: 04546540675965
• UDI-Public: 04546540675965
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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: 08/29/2024
• Device Model Number: M0035425150
• Device Catalogue Number: M0035425150
• Device Lot Number: 23135150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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: 1310 GUIDEWIRE (UNKNOWN); CODIS 6F DISTAL CATHETER (CORDIS); EXCELSIOR SL-10 MICROCATHETER (STRYKER); EXCELSIOR XT-27 CATHETER (STRYKER); INZONE POWER SUPPLY SYSTEM (STRYKER); NEUROFORM EZ STENT (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Race: Asian