MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW US 2.50MM X 15MM; CATHETER, BALLOON TYPE

Catalog Number	M0032072215250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperemia (1904); Vascular Dissection (3160)
Date of Event	04/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is for the first device out of 3.The device was disposed at the facility.
Event or Problem Description
The patient presented with an intracranial atherosclerotic disease of the left m1 middle cerebral (mca) with 95% of stenosis.It was reported that following angioplasty using the first balloon (subject device), a stent was placed across the most severe stenosis of the left m1 mca.Initially complete mca revascularization was achieved; however, final angiograms showed a small flap dissection at the end of the stent.The dissection was treated with the second balloon and another manufacturer's stent placed across the dissected lesion.The patient remains intubated overnight.The next day, the patient showed signs of the reperfusion issues.The patient became generally weaker with more pronounced left weakness.Computed tomography (ct) scan confirmed re-perfusion hyperemia in the left cerebral hemisphere with no bleeding and no new stroke.No treatment was required and seven days post procedure, the patient was discharged to a skilled nursing facility for rehabilitation.The patient had significant recovery of function prior to discharge with return to baseline at the rehabilitation center one week after discharge.The event was reported as related to the procedure but unrelated to devices.
Additional Manufacturer Narrative
Patient's gender was corrected.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, vessel dissection and reperfusion hyperemia are known risk 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 or Problem Description
The patient presented with an intracranial atherosclerotic disease of the left m1 middle cerebral (mca) with 95% of stenosis.It was reported that following angioplasty using the first balloon (subject device), a stent was placed across the most severe stenosis of the left m1 mca.Initially complete mca revascularization was achieved; however, final angiograms showed a small flap dissection at the end of the stent.The dissection was treated with the second balloon and another manufacturer's stent placed across the dissected lesion.The patient remains intubated overnight.The next day, the patient showed signs of the reperfusion issues.The patient became generally weaker with more pronounced left weakness.Computed tomography (ct) scan confirmed reperperfusion hyperemia in the left cerebral hemisphere with no bleeding and no new stroke.No treatment was required and seven days post procedure, the patient was discharged to a skilled nursing facility for rehabilitation.The patient had significant recovery of function prior to discharge with return to baseline at the rehabilitation center one week after discharge.The event was reported as related to the procedure but unrelated to devices.

• Brand Name: FG GATEWAY OTW US 2.50MM X 15MM
• Common Device Name: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 5657886
• Report Number: 3008853977-2016-00182
• Device Sequence Number: 250132
• Product Code: GBA
• UDI-Device Identifier: 08714729791188
• UDI-Public: (01)08714729791188(17)180930(10)18377213
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 04/18/2016

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: 09/30/2018
• Device Catalogue Number: M0032072215250
• Device Lot Number: 18377213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2016
• Supplement Report FDA Received Date: 08/04/2016
• 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: 77 YR