MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW US 1.50MM X 9MM; CATHETER, BALLOON TYPE

Catalog Number M0032072209150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982)

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

This is 1 out of 2 reports.The device was disposed at the facility.

Event Description

It was reported that following angioplasty with the subject balloon, a stent was placed across the 82% stenosed left middle cerebral artery (mca) m1 lesion.The procedure was successfully completed.Post procedure, the patient opened eyes, followed simple commands, moved all extremities.The next day, it was noted that the patient had aphasia and cannot move the right arm.Computated tomography (ct) head scan and magnetic resonance imaging (mri) indicated an in-stent thrombosis and an extensive infarct in the treated left mca territory.The stroke was measured with a national institute of health stroke scale (nihss) score of 19 and that patient's disability was measured with a modified rankin scale score of 5 ( baseline mrs was measured of 0).Adverse events were treated with medications (not specified).The patient is still in the hospital with nihss score of 20 and mrs of 5.The physician suspected that in-stent thrombosis and stroke occurred due to the patient was unresponsive to antiplatelet drug medication.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, stroke and d neurological deficit are known risks associated with endovascular procedures and are listed as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.

Event Description

It was reported that following angioplasty with the subject balloon, a stent was placed across the 82% stenosed left middle cerebral artery (mca) m1 lesion.The procedure was successfully completed.Post procedure, the patient opened eyes, followed simple commands, moved all extremities.The next day, it was noted that the patient had aphasia and cannot move the right arm.Computated tomography (ct) head scan and magnetic resonance imaging (mri) indicated an in-stent thrombosis and an extensive infarct in the treated left mca territory.The stroke was measured with a national institute of health stroke scale (nihss) score of 19 and that patient's disability was measured with a modified rankin scale score of 5 ( baseline mrs was measured of 0).Adverse events were treated with medications (not specified).The patient is still in the hospital with nihss score of 20 and mrs of 5.The physician suspected that in-stent thrombosis and stroke occurred due to the patient was unresponsive to antiplatelet drug medication.

• Brand Name: FG GATEWAY OTW US 1.50MM X 9MM
• Type of Device: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer Contact: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5761514
• MDR Text Key: 48537458
• Report Number: 0002134265-2016-00012
• Device Sequence Number: 1
• Product Code: GBA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M0032072209150
• Device Lot Number: 17250473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR