MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW US 2.75MM X 15MM CATHETER, BALLOON TYPE

Catalog Number M0032072215270

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

Patient Problems Stroke/CVA (1770); Hemorrhage, Intraventricular (1892); Hydrocephalus (3272)

Event Date 01/24/2015

Event Type  Death  

Event Description

The physician successfully performed a balloon (subject device) angioplasty of the target right supraclinoid internal carotid artery (ica) 97 % stenosed lesion. Post dilation, the imaging showed excellent restoration of near normal antegrade flow through the supraclinoid into both anterior and middle cerebral branches. Following angioplasty, a stent was uneventfully placed across the target lesion and excellent blood flow restoration was achieved. There was no complication noted during the procedure. However, two days post procedure, a new parenchymal intraventricular hemorrhage resulting in a stroke and a hydrocephalus was observed. The patient was treated with fresh frozen plasma. The antiplatelets were reversed to platelets. The patient's condition improved; however, five days post the stroke onset, the patient suddenly became unresponsive and hemiplegic on the left side. The patient was given ativant and loaded with keppra. Imaging showed a new large hemispheric acute infarct consistent with occlusion of the stent. The patient became unresponsive and nine days post procedure, the patient died. The physician stated that the etiology of the bleeding was reperfusion injury and related to the procedure but not related to the implanted stent and the balloon device.

Event Description

The physician successfully performed a balloon (subject device) angioplasty of the target right supraclinoid internal carotid artery (ica) 97 % stenosed lesion. Post dilation, the imaging showed excellent restoration of near normal antegrade flow through the supraclinoid into both anterior and middle cerebral branches. Following angioplasty, a stent was uneventfully placed across the target lesion and excellent blood flow restoration was achieved. There was no complication noted during the procedure. However, two days post procedure, a new parenchymal intraventricular hemorrhage resulting in a stroke and a hydrocephalus was observed. The patient was treated with fresh frozen plasma. The antiplatelets were reversed to platelets. The patient's condition improved; however, five days post the stroke onset, the patient suddenly became unresponsive and hemiplegic on the left side. The patient was given ativan and loaded with keppra. Imaging showed a new large hemispheric acute infarct consistent with occlusion of the stent. The patient became unresponsive and nine days post procedure, the patient died. The physician stated that the etiology of the bleeding was reperfusion injury and related to the procedure but not related to the implanted stent and the balloon device.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications. Hemorrhage, stroke, neurological complications and death are known and anticipated complications to these types of procedures and are noted in the labeling. Therefore, it was determined that the reported event was an anticipated patient complication.

Manufacturer Narrative

The device is not available to the manufacturer.

• Brand Name: FG GATEWAY OTW US 2.75MM 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: alyson harris ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 4492435
• MDR Text Key: 5446442
• Report Number: 3008853977-2015-00044
• Device Sequence Number: 1
• Product Code: LIT
• 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

• Type of Report: Initial,Followup
• Report Date: 01/26/2015

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/06/2015
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: M0032072215270
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Date Manufacturer Received: 02/12/2015
• 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 TREATMENT DATA

Date Received: 02/06/2015 Patient Sequence Number: 1

Treatment

WINGSPAN STENT DELIVERY SYSTEM (STRYKER)