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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

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BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number H7493926008270
Device Problem Occlusion Within Device (1423)
Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Thrombosis (2100); ST Segment Depression (2487)
Event Date 08/12/2017
Event Type  Injury  
Manufacturer Narrative
Device is a combination product. Device evaluated by mfr. : the complaint device was not received for analysis. A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures/current controls as per the product specification. The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu. (b)(4).
 
Event Description
Same case as mdr id: 2134265-2017-08809. It was reported that stent thrombosis occurred. In (b)(6) 2017, the patient presented with non-st-elevation myocardial infarction (n-stemi) and acute coronary syndrome. Vascular access was obtained via the left radial artery utilizing modified seldinger technique. A 5fr radial sheath was inserted over the guidewire without difficulty. Following diagnostic coronary angiography, coronary invention was performed using 6fr guiding catheter to cannulate the right coronary artery (rca). A 0. 014 non-bsc angioplasty guidewire was advanced distally, and crossed the subtotal occlusion of the right posterolateral branch and advanced distally. Dilatation was performed using a 2. 5 x 12mm emerge balloon catheter followed by stenting using 2. 50 x 12 synergy ii drug-eluting stent deployed at 14 atmospheres for 30 seconds. The initial 99% in-stent restenosis (isr) was reduced resulting in 0% residual with normal timi-3 flow and grade 3 perfusion. A 6 fr non-bsc guide catheter was then used to cannulate the 90% stenosed left main coronary artery. A 0. 014 non-bsc angioplasty guidewire was used to cross the subtotal occlusion of the ostial left main coronary artery and advanced into the circumflex artery. Primary stenting was performed using 2. 75 x 8 synergy ii drug-eluting stent that was deployed at 22 atmospheres for 30 seconds reducing the initial subtotal occlusion to less than 10% residual with normal flow. Post procedure, the patient was given aspirin. The patient tolerated the procedure well with no complication. Five days after, the patient was brought in by emergency medical services (ems) with complaints of severe substernal chest pain which was unrelenting despite iv heparin and sublingual nitroglycerin. The patient had marked st-t depression in the inferior and the anteroseptal leads suggesting possibility true posterior wall infarct. The patient also developed atrial fibrillation at that time and was hypertensive with a blood pressure in the 90¿s. The patient was in significant distress and looked moribund. The patient was taken to the cardiac cath lab on emergent basis. A pacemaker was placed as a backup in the inferior vena cava. It was noted that the rca had thrombotic occlusion of the posterolateral artery (pla) branch and the left main was also occluded. A non-bsc guide catheter engaged the pla, a non-bsc wire was passed across the thrombotic occlusion, and a 2. 5 x15mm balloon was dilated which improved the flow. The flow in the pla was timi 2. The patient was then given boluses of intra-arterial adenosine. The angioplasty of the left main was done by placement of a non-bsc wire into the left main and passing into the left circumflex artery. Dilatation of the left main was done with a 2. 5 x 15 mm balloon followed by angioplasty of the left circumflex artery with 2. 0 x 20 mm balloon. Improvement in the flow was noted and the angiographic images were restored to baseline. An intra-aortic balloon pump was placed at one-to-one augmentation. Prior to this, the patient was in normal sinus rhythm from the presenting rhythm of atrial fibrillation. Once the balloon pump was placed, the blood pressure improved to 125/70 mmhg. The patient's chest pain almost abated except having some left shoulder pain. The patient was given tirofiban bolus and infusion was started. The patient would be given 180mg of ticagrelor once stabilized. The procedure was considered a successful restoration of flow in the pla, left main and circumflex arteries.
 
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Brand NameSYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Type of DeviceBIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6855598
MDR Text Key85663085
Report Number2134265-2017-08813
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150003
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 08/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/04/2018
Device Model NumberH7493926008270
Device Catalogue Number39260-0827
Device Lot Number20155285
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 Received08/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2017
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: 09/11/2017 Patient Sequence Number: 1
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