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

Model Number	M0035475150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that endoneurovascular aneurysmal coil embolization was planned for ruptured aneurysm case.During the procedure it was reported that the subject coil was ¾ deployed in a ruptured aneurysm when the physician noticed it was no longer easy to deploy.Physician tried to retract the subject coil.It would not deploy or come back into the microcatheter.Physician had to pull microcatheter all the way out leaving the subject coil.It snapped off delivery wire and was left hanging in the mca (middle cerebral artery).Stent was used to pin the coil into mca (middle cerebral artery).Two-hour of surgical delay was noted due to the reported issue and the patient was under general anesthesia at the time of event.No other information is available.
Additional Manufacturer Narrative
H3 summary attached - updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date ¿ added.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the coil delivery wire was found to be kinked/bent.The main coil was found to be broken/fractured.The main coil was not returned.The coil introducer sheath 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.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.During analysis, the main coil was found to be broken/fractured.An assignable cause of procedural factors will be assigned to the as reported (ar) and as analyzed (aa) 'main coil broken/fractured during use' as the defect is 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 handling damage will be assigned to the an assignable 'coil delivery wire kinked/bent' since it is most likely that this damage occurred due to handling of delivery wire during the clinical procedure.
Event or Problem Description
It was reported that endoneurovascular aneurysmal coil embolization was planned for ruptured aneurysm case.During the procedure it was reported that the subject coil was ¾ deployed in a ruptured aneurysm when the physician noticed it was no longer easy to deploy.Physician tried to retract the subject coil.It would not deploy or come back into the microcatheter.Physician had to pull microcatheter all the way out leaving the subject coil.It snapped off delivery wire and was left hanging in the mca (middle cerebral artery).Stent was used to pin the coil into mca (middle cerebral artery).Two-hour of surgical delay was noted due to the reported issue and the patient was under general anesthesia at the time of event.No other information is available.

• Brand Name: TARGET 360 SOFT 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: 14060380
• Report Number: 3008881809-2022-00163
• Device Sequence Number: 4614692
• Product Code: HCG
• UDI-Device Identifier: 04546540676504
• UDI-Public: 04546540676504
• 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
• Report Date (Section B): 06/08/2022

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: 01/11/2025
• Device Model Number: M0035475150
• Device Catalogue Number: M0035475150
• Device Lot Number: 23412448
• 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: 03/31/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• 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: NEUROFORM ATLAS STENT (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown