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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); ST Segment Elevation (2059); Thrombosis (2100); Vascular Dissection (3160)
Event Date 08/29/2018
Event Type  Injury  
Event Description
On an unspecified date, a couple of months ago, multiple layers of stents were placed. The patient presented with restenosis of the previously implanted stents. Vascular access was attempted via the radial artery prior to access being obtained via the femoral artery. The target lesion was located in the mid left anterior descending artery (lad). After a 3. 5mm non-bsc guide catheter and another non-bsc wire were used to cross the lesion, an emerge balloon catheter was advanced for dilatation. The wire knuckled going down. A 3. 00 x 16mm synergy ii drug-eluting stent was implanted in the mid lad. A 3. 0x12mm nc quantum balloon catheter was advanced for post dilatation but the device failed to cross. A 3. 0x12mm non-bsc balloon was advanced and post dilation was performed. The stent looked fine but there did seem to be a tight lesion in the proximal circumflex. The cardiologist did attempt radial prior to femoral approach. There was a possible perforation or dissection in the brachial area. The patient was in stable condition and went to recovery. Twenty to thirty minutes post stent deployment, the patient experienced st elevation and chest pain and was brought back to the lab. Vascular access was obtained via the left groin. Thrombosis was noted in proximal lad to distal area. The lad was wired and ballooned and the flow was restored. A possible distal dissection was noted and additional synergy stents were implanted to cover the dissection with timi 3 flow post procedure. The patient was unstable with low blood pressure and atrial fibrillation. The patient was placed on three pressures and synchronized cardioverted. The patient was transferred to cardiovascular intensive care unit in critical condition. The patient was still conscious and alert on bilevel positive airway pressure. No further patient complications were reported and the patient was stable.
 
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Brand NameEMERGE
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
maple grove
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key7906572
MDR Text Key121619534
Report Number2134265-2018-61197
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2018
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: 09/25/2018 Patient Sequence Number: 1
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