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

Catalog Number M0032072215150

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

Patient Problems Stroke/CVA (1770); Death (1802); Hemorrhage, Cerebral (1889)

Event Date 04/28/2016

Event Type  Death  

Manufacturer Narrative

This report is the second out of 2.The device was disposed at the facility.

Event Description

Following balloon (subject device) angioplasty, a stent was implanted to treat a 96% stenosed m1 middle cerebral artery (mca) lesion.Approximately 6 hours post procedure, it was noted that the patient mental status changed.Computed tomography (ct) scan confirmed that a massive cerebral hemorrhage resulted in a stroke with subsequent brain midline shift occurred, which led the following day to the patient's death.

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, hemorrhage, stroke and death 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

Following balloon (subject device) angioplasty, a stent was implanted to treat a 96% stenosed m1 middle cerebral artery (mca) lesion.Approximately 6 hours post procedure, it was noted that the patient mental status changed.Computed tomography (ct) scan confirmed that a massive cerebral hemorrhage resulted in a stroke with subsequent brain midline shift occurred, which led the following day to the patient's death.

• Brand Name: FG GATEWAY OTW US 1.50MM 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: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5686973
• MDR Text Key: 46158347
• Report Number: 0002134265-2016-00006
• Device Sequence Number: 0
• Product Code: PAV
• 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: 05/02/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0032072215150
• Device Lot Number: 16446787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2013
• 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): Death; Other
• Patient Age: 67 YR