MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422040
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during coil embolization procedure, the coil (subject device) did not completely detach at first and after detachment, the coil tail was left sticking out the aneurysm.There were no clinical consequences to the patient.
Event or Problem Description
It was reported that during coil embolization procedure, the coil (subject device) did not completely detach at first and after detachment, the coil tail was left sticking out the aneurysm.The patient was kept on aspirin for one month.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.The device was returned without the main coil.Visual examination of the returned delivery wire revealed that the coil proximal contact and delivery wire were kinked, likely due to handling of the device during the procedure and leading to the reported false detachment signal (partial detachment).In the case of this complaint it was reported that: ' the inzone detachment system gave a detachment tone but coil didn't completely detach.' the additional information states that the coil detached but a tail was left sticking out the aneurysm.The coil protruded from the aneurysm was most likely due to some procedural/anatomical factors encountered during the procedure (possibly due to the false detachment signal - the physician assumed the coil had detached and pulled the device out).Therefore, an assignable cause of procedural factors has been assigned to the reported coil protrusion.

• Brand Name: TARGET 360 ULTRA 2MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7907177
• Report Number: 3008881809-2018-00417
• Device Sequence Number: 1526892
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: 04546540675842
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 10/25/2018

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: 08/31/2020
• Device Catalogue Number: M0035422040
• Device Lot Number: 19930673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/25/2018
• 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 MICROCATEHTER (STRYKER); INZONE DETACHMENT SYSTEM (STRYKER0
• Outcome Attributed to Adverse Event: Required Intervention