MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035476300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that the subject coil was used during coil embolization procedure for aneurysm located at the anterior communicating artery (acom).The physician was able to place the subject coil into the aneurysm; however, the coil became stretched and was prematurely detached from the primary wire.There were no clinical consequences reported due to this event.No additional information was provided.
Event or Problem Description
It was reported that the subject coil was used during coil embolization procedure for aneurysm located at the anterior communicating artery (acom).The physician was able to place the subject coil into the aneurysm; however, the coil became stretched and was prematurely detached from the primary wire.The physician accessed the vessel and a microsnare device was used to remove the coil.The procedure took longer than it was supposed to have, and the patient was under general anesthesia for 1.5 hours due to the procedure.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the delivery wire of the coil was found kinked/bent and the suture was noted to be damaged.The main coil was broken near the proximal end and excessively stretched.Functional testing was not performed due to the damage noted to the returned device.In case of this complaint, it is possible that the coil got stuck inside the microcatheter and excessive force was used in order to push/pull the coil against friction, as a result of the coil was stretched and broken; however, this cannot be conclusively determined.Based on the investigation results and available information an assignable cause of procedural factors was assigned to the as reported issues 'nv - main coil stretched, 'nv - main coil prematurely detached/separated inside patient', and to an analyzed issues 'nv - main coil broken/fractured', and ' main coil suture damage', as the issues are associated with a product that meets stryker design and manufacture specifications and was used in according with the direction for use (dfu) but due to procedural and/or anatomical factors during use, the device performance was limited.The delivery wire was kinked most likely due to handling of the device during the procedure; therefore, an assignable cause of handling damage was assigned to the as analyzed issue 'nv- coil delivery wire kinked/bent'.
Event or Problem Description
It was reported that the subject coil was used during coil embolization procedure for aneurysm located at the anterior communicating artery (acom).The physician was able to place the subject coil into the aneurysm; however, the coil became stretched and was prematurely detached from the primary wire.The physician accessed the vessel and a microsnare device was used to remove the coil.The procedure took longer than it was supposed to have, and the patient was under general anesthesia for 1.5 hours due to the procedure.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8175350
• Report Number: 3008881809-2018-00537
• Device Sequence Number: 2745575
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: 04546540676559
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup
• Report Date (Section B): 02/12/2019

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: 02/25/2021
• Device Catalogue Number: M0035476300
• Device Lot Number: 20361270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 12/19/2018; 01/16/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/11/2019; 02/12/2019
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention