MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW US 2.00MM X 15MM; CATHETER, BALLOON TYPE

Catalog Number M0032072215200

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

Patient Problems Infarction, Cerebral (1771); Neurological Deficit/Dysfunction (1982)

Event Date 08/02/2016

Event Type  Injury  

Manufacturer Narrative

This is 3 of 3 reports filed for stent, assisted angioplasty, for the subject reported event.The subject device is not available.

Event 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 4with 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.

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 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.

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 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 4with 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 2.00MM X 15MM
• 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: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5963862
• MDR Text Key: 55160779
• Report Number: 0002134265-2016-00023
• 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,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2017
• Device Catalogue Number: M0032072215200
• Device Lot Number: 17102896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2014
• 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
• Treatment: GATEWAY BALLOON (BOSTON SCIENTIFIC); WINGSPAN (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 77 YR