MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10606
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Atrial Flutter (1730); Chest Pain (1776); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
(b)(6) clinical study.It was reported that patient experienced chest pain, myocardial infarction, cardiac enzyme elevation and stent thrombosis occurred.In (b)(6) 2019, the patient presented with an ejection fraction of 55%.Forty one days after, index procedure was performed.The patient present with angina and was referred for cardiac catherization target lesion #1 was located in distal left circumflex (lcx) artery with 80% stenosis and was 30 mm long with a reference vessel diameter of 4.0 mm.Target lesion #1 was treated with direct placement of 4.5 mm x 32 mm study stent following which residual stenosis was noted to be 0%.Non-target lesion #1 was located in obtuse marginal (om1) and was treated with the placement of 2.75 mm x 20mm synergy drug-eluting stent (des).Non-target lesion #2 was located in proximal lcx extending to om1 and was treated with the placement of 3.50 mm x 32 mm of synergy des.Non-target lesion #3 was located in proximal lcx and was treated with the placement of 4.00 mm x 32mm synergy des.Non-target lesion #4 was located in distal lcx (same as that of target lesion) and was treated with the placement of 4.00 mm x 8.00mm synergy des.The subject was discharged on dual antiplatelet therapy on the same day.In (b)(6) 2020, subject was brought to the emergency department with complaints of severe chest pain with burping sensation.The subject was diagnosed with atrial flutter with rapid ventricular response with rate in the 130s and subject was treated with 150mg of iv amiodarone.Following which, rate decreased to 100-115 range and chest discomfort improved.On the same day, electrocardiogram revealed wide qrs tachycardia with fusion complexes possible atrial flutter with 2:1 and left bundle branch block.Subject was put on nitro paste.On the same day, cardiac enzyme was noted to be elevated consistent with protocol definition of spontaneous myocardial infarction (mi).The subject was diagnosed with non-st segment elevation myocardial infarction (nstemi) caused by acute atherothrombotic coronary artery disease and was hospitalized for further monitoring.The subject was on aspirin and apixaban.Therapy with beta blocker was continued.Subject was further administered with an additional 2.5 mg of iv metoprolol and apixaban was put on hold with plan to start heparin.The subject was on telemetry and was cautious not to be overly aggressive due to the history of 1st degree av block.A day after, ecg revealed atrial flutter with 4:1 av conduction, cannot rule out inferior infarct age undetermined, st and t wave abnormality considering anterolateral ischemia.Lbbb was no longer present.100% occlusion in om1 secondary to stent thrombosis was treated with balloon angioplasty with restoration of timi 3 flow.Ivus revealed evidence of stent thrombosis and hence stent was dilated and no new stent was placed due to poor outflow.Om1 and lcx bifurcation was treated with simultaneous kissing balloon inflation.Subject converted to normal sinus rhythm on own.Subject preferred medical therapy due to high rate long term success.Two days after, subject was discharged on ticagrelor and apixaban.Aspirin and clopidogrel were discontinued.Four days after, subject was noted with atrial flutter with rapid ventricular response.Cardiac enzyme was noted to be elevated.The subject was discharged on the same day and the event was not recovered/not resolved.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10810029
• Report Number: 2134265-2020-15523
• Device Sequence Number: 11806520
• Product Code: NIQ
• UDI-Device Identifier: 08714729840367
• UDI-Public: 08714729840367
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2021
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0024404247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/09/2020
• 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: Required Intervention
• Patient Age: 79 YR