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	H7493926008270
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Thrombosis (2100); ST Segment Depression (2487)
Date of Event	08/12/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6855598
• Report Number: 2134265-2017-08813
• Device Sequence Number: 659684
• Product Code: NIQ
• UDI-Device Identifier: 08714729839989
• UDI-Public: (01)08714729839989(17)20180104(10)20155285
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2018
• Device Model Number: H7493926008270
• Device Catalogue Number: 39260-0827
• Device Lot Number: 20155285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 69