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

Model Number H7493926012250

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: 2134265-2017-08813.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.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE 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 Key: 6855604
• MDR Text Key: 85662617
• Report Number: 2134265-2017-08809
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840039
• UDI-Public: (01)08714729840039(17)20180403(10)0020506400
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2018
• Device Model Number: H7493926012250
• Device Catalogue Number: 39260-1225
• Device Lot Number: 0020506400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 69