MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035425150
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during coil embolization procedure, the physician was trying to detach a coil (subject device) with a detachment system but it sounds a long beep and the physician did not try to press the detachment button again.When trying to pull back on the coil delivery wire, it was noticed that the coil was still attached.After several unsuccessful manipulations, it was noticed while trying to retract the coil out of the microcatheter, that 6-8 com of the coil was protruding out of the aneurysm.Stenting was undertaken to try to tack down the protruding coil against the internal carotid artery (ica).The microcatheter was then pulled back and the coil was then detached successfully.Another stent was placed to tack down the protruding coil.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that the coil proximal contact and coil delivery wire were kinked.The main coil was not returned for analysis as it was implanted.The returned delivery wire was inspected, and the main coil appears to have detached electrolytically.Procedural fluid was noted on the device which can cause detachment issues.The anatomy was also noted to be tortuous.The proximal contact was damaged when received for analysis which can affect the detachment.An assignable cause of procedural factors will be assigned to the main coil protrusion and main coil stretched.An assignable cause of handling damage will be assigned to the as reported/as analyzed main coil failed/unable to detach and to the as analyzed coil proximal contact and coil delivery wire kink.
Event or Problem Description
It was reported that during coil embolization procedure, the physician was trying to detach a coil (subject device) with a detachment system but it sounds a long beep and the physician did not try to press the detachment button again.When trying to pull back on the coil delivery wire, it was noticed that the coil was still attached.After several unsuccessful manipulations, it was noticed while trying to retract the coil out of the micocatehter, that 6-8 com of the coil was protruding out of the aneurysm.Stenting was undertaken to try to tack down the protruding coil against the internal carotid artery (ica).The microcatheter was then pulled back and the coil was then detached successfully.Another stent was placed to tack down the protruding coil.There were no clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 5MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8129497
• Report Number: 3008881809-2018-00509
• Device Sequence Number: 19248626
• Product Code: HCG
• UDI-Device Identifier: 04546540675965
• UDI-Public: 04546540675965
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: M0035425150
• Device Lot Number: 20086939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/29/2019
• 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); EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention