MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED J 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M0031681920
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	07/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 2 of 2 reports.The subject device is not returned.
Event or Problem Description
The case was ruptured c2-3 aneurysm stent assisted coil embolization, the stent was deployed without any problems.The stent delivery wire (sdw) was attempted to be withdrawn but the sdw and the stent got stuck each other.The microcatheter (subject device) was advanced to release the sticking, but it also stuck with the sdw.The hub of the microcatheter was cut off and snare device was navigated to the sdw via the microcatheter outer shaft.The snare device caught the sdw, then the sdw and the microcatheter were removed from the patient while involving a slight stent displacement.The removed sdw tip was found stretched and separated.Coiling was started, but a distal blood flow of the aneurysm came not to be shown in angiography during coiling.Cross flow from opposite side was sufficient, so the procedure was finished without recanalization of the distal blood flow.The patient's condition is brain death due to the preexisting sub arachnoid hemorrhage worsening.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.However, thrombosis is a known risk associated with endovascular procedure and is noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
The case was ruptured c2-3 aneurysm stent assisted coil embolization, the stent was deployed without any problems.The stent delivery wire (sdw) was attempted to be withdrawn but the sdw and the stent got stuck each other.The microcatheter (subject device) was advanced to release the sticking, but it also stuck with the sdw.The hub of the microcatheter was cut off and snare device was navigated to the sdw via the microcatheter outer shaft.The snare device caught the sdw, then the sdw and the microcatheter were removed from the patient while involving a slight stent displacement.The removed sdw tip was found stretched and separated.Coiling was started, but a distal blood flow of the aneurysm came not to be shown in angiography during coiling.Cross flow from opposite side was sufficient, so the procedure was finished without recanalization of the distal blood flow.The patient's condition is brain death due to the preexisting sub arachnoid hemorrhage worsening.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED J 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7754655
• Report Number: 3008881809-2018-00333
• Device Sequence Number: 1702937
• Product Code: DQY
• UDI-Device Identifier: 04546540688248
• UDI-Public: 04546540688248
• Combination Product (Y/N): N
• PMA/510(K) Number: K042568
• 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): 09/14/2018

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: No Information
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: M0031681920
• Device Lot Number: 20240961
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 09/14/2018
• 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: NEUROFORM ATLAS STENT (MICROCATHETER)
• Outcome Attributed to Adverse Event: Other; Required Intervention