MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M00345100950
Medical Device Problem Codes	Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	07/10/2020
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 procedure for coiling of aneurysm, subject coil was noted to be unable to detach.The detachment system failed to indicate that the subject coil did not detach successfully.One subject coil loop remained in vessel.Patient experienced icb (intracranial bleeding) and sah (subarachnoid hemorrhage).The procedure was completed successfully, no further information available.
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.Device was returned for analysis, the lot number was not reported, however there was packaging returned with the device, it cannot be definitively determined if this is the correct lot number for the suspect device.During visual inspection, there was kinking noted to the delivery wire at 14cm & 131cm from the proximal end.The main coil was noted to have been detached electrolytically and not returned, there was some evidence of blood/thrombus to the detachment area.During functional testing, a detachment test was unable to be performed as the main coil had been detached.The reported event was not definitively confirmed based on the device analysis.The device failed to meet specification when returned, based on the damage noted.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 subject coil was returned, and it was confirmed that the coil had detached electrolytically.It is possible that there may have been partial detachment of the coil causing movement of the coil during the movement/removal attempt, however this cannot be definitively determined.It cannot be definitively determined if the reported patient intracranial hemorrhage, is related to the device, therefore an assignable cause of undeterminable will be assigned.An assignable cause of not confirmed, will be assigned to the reported main coil failed/unable to detach as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.An assignable cause of procedural factors will be assigned to the reported main coil protrusion, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.The returned delivery wire was kinked, it is likely to have occurred as a result of handing of the device during use, therefore an assignable cause of handling damage will be assigned to the analyzed coil delivery wire kinked/bent.
Event or Problem Description
It was reported that during procedure for coiling of aneurysm, subject coil was noted to be unable to detach.The detachment system failed to indicate that the subject coil did not detach successfully.One subject coil loop remained in vessel.Patient experienced icb (intracranial bleeding) and sah (subarachnoid hemorrhage).The procedure was completed successfully, no further information available.

• Brand Name: TARGET 360 NANO 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10360309
• Report Number: 3008881809-2020-00226
• Device Sequence Number: 19070281
• Product Code: HCG
• UDI-Device Identifier: 04546540697950
• UDI-Public: 04546540697950
• Combination Product (Y/N): N
• 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): 01/19/2021

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: 01/11/2023
• Device Model Number: M00345100950
• Device Catalogue Number: M0035443060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INZONE DETACHMENT SYSTEM (STRYKER); TARGET DETACHABLE COIL (STRYKER); INZONE DETACHMENT SYSTEM (STRYKER); TARGET DETACHABLE COIL (STRYKER)
• Outcome Attributed to Adverse Event: Other