MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW JP 2.00MM X 9MM; CATHETER, BALLOON TYPE

Catalog Number M0032072009200

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

Patient Problems Death (1802); Hemorrhage, Cerebral (1889); Vascular Dissection (3160)

Event Date 07/30/2015

Event Type  Death  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that during percutaneous transluminal angioplasty procedure (pta) at 9 atm for 30 seconds for a left mca stenosis (91.6% occlusion and lesion length of 4.6mm) with the subject device, dissection occurred at the lesion location.Medical intervention was performed by placement of a stent system.Hyperperfusion was observed immediately after angiography.Five hours and a half post- procedure the patient developed putaminal hemorrhage and expired.No medical treatment was performed.

• Brand Name: FG GATEWAY OTW JP 2.00MM 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: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6169702
• MDR Text Key: 62226576
• Report Number: 0002134265-2016-00035
• Device Sequence Number: 0
• Product Code: PAV
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0032072009200
• Device Lot Number: 17347888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/13/2016
• 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
• Treatment: WINGSPAN STENT SYSTEM (STRYKER)
• Patient Outcome(s): Death; Other; Required Intervention
• Patient Age: 75 YR