MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 3MMX8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035463080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Rupture (2208)
Date of Event	05/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 1 of the 4 reports.The device remains in patient.
Event or Problem Description
During the embolization procedure for the aneurysm with the status of sah (subarachnoid hemorrhage) at a-com artery, it was reported that the subject coil was implanted and then the intraoperative rupture occurred.The rupture was resolved by implanting additional coils and the patient recovered.
Additional Manufacturer Narrative
A review of the device history record could not be performed because the lot number was not reported.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.The reported aneurysm burst (rupture) is known risks associated with endovascular procedures and are listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication has been assigned to the reported event.
Event or Problem Description
During the embolization procedure for the aneurysm with the status of sah (subarachnoid hemorrhage) at a-com artery, it was reported that the subject coil was implanted and then the intraoperative rupture occurred.The rupture was resolved by implanting additional coils and the patient recovered.

• Brand Name: TARGET 360 STANDARD 3MMX8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7612382
• Report Number: 3008881809-2018-00266
• Device Sequence Number: 16526411
• Product Code: HCG
• UDI-Device Identifier: 07613252192558
• UDI-Public: 07613252192558
• 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): 08/01/2018

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?: No
• Operator of Device: No Information
• Device Catalogue Number: M0035463080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 49 YR