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

Catalog Number	M0035423060
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	01/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during procedure by coiling an anterior communicating artery (acom) aneurysm, the coil (subject device) did not detach.After multiple attempts to detach the coil, the physician decided to pull back the coil in the middle of microcatheter and part of the coil remained in the aneurysm.Later on, the proximal part of the coil migrated from the catheter and occluded the anterior cerebral artery (aca).There were no medical consequences to the patient.
Additional Manufacturer Narrative
Based on the results of the dhr (device history record), there is no indication that the device, labelling or packaging failed to meet its specifications when released.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not 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 patient vessel occlusion while anticipated in nature as per the dfu is likely to be due to the main coil damage.While there are several potential causes for the reported issues, because review and analysis of available information failed to identify a definitive cause, and because the device was not returned a cause of undeterminable was assigned.
Event or Problem Description
It was reported that during procedure by coiling an anterior communicating artery (acom) aneurysm, the coil (subject device) did not detach.After multiple attempts to detach the coil, the physician decided to pull back the coil in the middle of microcatheter and part of the coil remained in the aneurysm.Later on, the proximal part of the coil migrated from the catheter and occluded the anterior cerebral artery (aca).There were no medical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8388721
• Report Number: 3008881809-2019-00063
• Device Sequence Number: 11275468
• Product Code: HCG
• UDI-Device Identifier: 04546540675880
• UDI-Public: 04546540675880
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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: 08/12/2021
• Device Catalogue Number: M0035423060
• Device Lot Number: 20785800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 03/12/2019
• 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: MICROCATHETER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR