MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW US 1.50MM X 15MM; CATHETER, BALLOON TYPE

Catalog Number	M0032072215150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Infarction, Cerebral (1771); Neurological Deficit/Dysfunction (1982)
Date of Event	08/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 2 of 3 reports filed for stent (1) assisted angioplasty (2) for the subject reported event.The subject device is not available.
Event or Problem Description
The patient with a baseline of a modified rankin scale (mrs) of 3 underwent successful stent assisted balloon angioplasty of the 87 % stenosed left middle cerebral artery (l mca).It was reported that post procedure the patient experienced a stroke in the basal ganglia (treated area).The patient stroke was assessed as a mrs of 4 with a national institute of health stroke scale (nihss) of 12.It was reported that medical therapy and rehabilitation have been provided and it is still ongoing.At discharge the patient had residual aphasia and right sided weakness.Upon discharge the patient was reported to have a mrs of 4 with a nihss of 9.The study facility indicated that the relationship of the procedure to the stroke was not related; however, to the device was unknown.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.However, hemorrhage and neurological symptoms are known risks associated with endovascular procedure and are 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 patient with a baseline of a modified rankin scale (mrs) of 3 underwent successful stent assisted balloon angioplasty of the 87 % stenosed left middle cerebral artery (l mca).It was reported that post procedure the patient experienced a stroke in the basal ganglia (treated area).The patient stroke was assessed as a mrs of 4 with a national institute of health stroke scale (nihss) of 12.It was reported that medical therapy and rehabilitation have been provided and it is still ongoing.At discharge the patient had residual aphasia and right sided weakness.Upon discharge the patient was reported to have a mrs of 4 with a nihss of 9.The study facility indicated that the relationship of the procedure to the stroke was not related; however, to the device was unknown.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.However, stroke and neurological symptoms are known risks associated with endovascular procedure and are 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 patient with a baseline of a modified rankin scale (mrs) of 3 underwent successful stent assisted balloon angioplasty of the 87 % stenosed left middle cerebral artery (l mca).It was reported that post procedure the patient experienced a stroke in the basal ganglia (treated area).The patient stroke was assessed as a mrs of 4 with a national institute of health stroke scale (nihss) of 12.It was reported that medical therapy and rehabilitation have been provided and it is still ongoing.At discharge the patient had residual aphasia and right sided weakness.Upon discharge the patient was reported to have a mrs of 4 with a nihss of 9.The study facility indicated that the relationship of the procedure to the stroke was not related; however, to the device was unknown.

• Brand Name: FG GATEWAY OTW US 1.50MM X 15MM
• Common Device Name: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 5963866
• Report Number: 0002134265-2016-00022
• Device Sequence Number: 19042335
• Product Code: GBA
• UDI-Device Identifier: 08714729791300
• UDI-Public: (01)08714729791300(17)180430(10)17881064
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2017

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: 04/30/2018
• Device Catalogue Number: M0032072215150
• Device Lot Number: 17881064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/26/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/20/2016
• Supplement Report FDA Received Date: 11/03/2016; 01/20/2017
• 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: GATEWAY BALLOON (BOSTON SCIENTIFIC); WINGSPAN STENT (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR