MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035473100
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that coil embolization procedure of aneurysm located on the anterior communicating artery (acom), it was difficult to introduce the last coil (subject device) into the aneurysm.The coil failed to be completely deployed after 5cm of its length.While trying to withdraw the coil, the coil stretched, detached, and crumpled within the carotid bifurcation.It took some time until the physician was able to withdraw the coil out of the aneurysm and out of the patient¿s body by using a stent retriever.The procedure was completed with another coil of the same size.There were no patient complications.
Additional Manufacturer Narrative
Based on returned product lot number, the device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned sample and it was observed that the delivery wire was kinked at the distal end and the main coil had prematurely detached at the detachment zone.The main coil was not returned.During functional test, the sheath was flushed, and the delivery wire was advanced without difficulty.Based on the device analysis, the as reported event was confirmed.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.As per the additional information, the coil failed to completely deploy within the aneurysm after several trials.The device was returned, and the main coil had been detached prematurely from the delivery, confirming the event.It is probable that the main coil prematurely detached during positioning within the aneurysm, causing the reported event.An assignable cause of procedural factors will be assigned to the reported issues and the analyzed premature detachment.It is probable that the delivery wire was kinked as a result of handling of the device during the clinical procedure.
Event or Problem Description
It was reported that coil embolization procedure of aneurysm located on the anterior communicating artery (acom), it was difficult to introduce the last coil (subject device) into the aneurysm.The coil failed to be completely deployed after 5cm of its length.While trying to withdraw the coil, the coil stretched, detached, and crumpled within the carotid bifurcation.It took some time until the physician was able to withdraw the coil out of the aneurysm and out of the patient¿s body by using a stent retriever.The procedure was completed with another coil of the same size.There were no patient complications.

• Brand Name: TARGET 360 SOFT 3MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8434713
• Report Number: 3008881809-2019-00074
• Device Sequence Number: 11076073
• Product Code: HCG
• UDI-Device Identifier: 07613252239475
• UDI-Public: 07613252239475
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: 07/25/2021
• Device Catalogue Number: M0035473100
• Device Lot Number: 20744803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/09/2019
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 60