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

The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.However, hemorrhage, vessel dissection, and patient outcome of death are known risks associated with endovascular procedures 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.This current report represents the initial and final report for this event.The original initial report number ¿0002134265-2016-00035¿ for this event should be deleted from the emdr system.The information contained within this report represents information contained in the original report number listed above and any supplemental information gathered that was not previously provided to fda.The information in this current report was not provided as a supplemental report to the original report number listed above because the original initial mdr report number may now considered a duplicate report number by fda¿s emdr system.¿ 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: michael reddick ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6479276
• MDR Text Key: 72327670
• Report Number: 0002134265-2017-30012
• Device Sequence Number: 0
• Product Code: PAV
• Combination Product (y/n): N
• 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: 04/10/2017

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 Expiration Date: 10/07/2017
• 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: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2016
• Is the Device Single Use?: Yes
• 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