MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036101240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the coil embolization procedure for a ruptured middle central artery (mca), it was reported that the coil was prematurely detached during reposition in the aneurysm.Therefore, the detached coil was removed with snare and thrombus was found on the coil.The procedure was successfully completed after replacing with another product.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the main coil was stretched and prematurely detached inside patient.In addition, the delivery wire was kinked and broken inside patient.As per the additional information, the flush was continuous.While patient thrombus is an anticipated complication it is most likely that anatomical or procedural factors encountered during the procedure contributed the patient vessel thrombosis encountered during the procedure.Therefore, a probable cause of procedural factors will be assigned to the main coil damage and the thrombus, as these defects appear to be associated with a product that met the design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.
Event or Problem Description
During the coil embolization procedure for a ruptured middle central artery (mca), it was reported that the coil was prematurely detached during reposition in the aneurysm.Therefore, the detached coil was removed with snare and thrombus was found on the coil.The procedure was successfully completed after replacing with another product.

• Brand Name: TARGET XL 360 STANDARD 12MM X 45CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8834802
• Report Number: 3008881809-2019-00215
• Device Sequence Number: 14081898
• Product Code: HCG
• UDI-Device Identifier: 04546540711281
• UDI-Public: 04546540711281
• 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): 09/20/2019

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: 09/23/2021
• Device Catalogue Number: M0036101240
• Device Lot Number: 20897490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 07/28/2019
• Supplement Report FDA Received Date: 09/20/2019
• 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: SL-10 MICROCATHETER (STRYKER); SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention