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

Catalog Number	M0035443060
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available.Therefore, functional testing as well as physical analysis cannot be performed.The reported event is covered in the device directions for use (dfu).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.Additional information indicated that no anomalies were noted to the device during preparation/prior to use and continuous flush was maintained.It is most likely that the main coil detached prematurely and broke inside the patient resulting in migration of fragments inside the vessel due to some handling issues or procedural factors encountered during use.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.The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that the coil(subject device) detached prematurely at the detachment zone inside the patient, a snare device was attempted to retrieve the coil, but a part of the coil was left in the aneurysm.The broken portion of the coil migrated into the neuro anatomy.The physician left the coil partially in vessel ica (internal carotid artery) and aca (anterior cerebral artery) and completed the procedure.The physician stated that the patient¿s poor condition post procedure was not related to unretrieved coil in the parent vessel.No further information is available.

• Brand Name: TARGET 360 NANO 3 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9082963
• Report Number: 3008881809-2019-00280
• Device Sequence Number: 11418710
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: 07613252600329
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 09/18/2019

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: 02/11/2022
• Device Catalogue Number: M0035443060
• Device Lot Number: 21195711
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention