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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MINN FG GATEWAY OTW US 2.75MM X 15MM CATHETER, BALLOON TYPE Back to Search Results
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.

 
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Brand NameFG GATEWAY OTW US 2.75MM X 15MM
Type of DeviceCATHETER, 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 Key4492435
MDR Text Key5446442
Report Number3008853977-2015-00044
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberH050001
Number of Events Reported1
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 Received02/06/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberM0032072215270
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/12/2015
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)
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