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

Device Problem Obstruction of Flow (2423)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Reocclusion (1985)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) clinical study.It was reported that in-stent restenosis (isr), myocardial infarction (mi) and chest pain occurred.In (b)(6) 2018, the patient had a 3.00 x 16 mm synergy stent implanted in the proximal left circumflex (lcx).In (b)(6) 2018, the patient presented with stable angina.Prior to procedure, the patient had indicative of ischemia and was referred for cardiac catheterization.Angiography revealed 80% stenosis in the proximal portion of the lcx which was treated with the implant of a 3.00 x 12 mm synergy stent.The angiography also revealed 90% stenosis in the proximal right coronary artery (rca) extending to mid rca, 44 mm long with a reference vessel diameter of 3 mm.The index procedure was performed and treated the lesion with pre-dilatation and placement of a 3.00 x 48 mm study stent.Following post-dilatation, residual stenosis was 0%.The patient was discharged the next day on dual antiplatelet therapy.In (b)(6) 2019, the patient presented to the emergency department (ed) with chest discomfort, burning chest sensation in the left upper extremities.The patient had taken nitroglycerin twice the previous night which had helped relieve the pain.The patient also had complaints of slight edema at the ankle and gi tract upset and reported several episodes of "tarry black stools".Upon arrival to ed, heparin drip and nitroglycerin was initiated.Blood pressure was difficult to control.Medications were adjusted by the nephrologist and the patient was started on hydralazine and admitted for further evaluation.Cardiac enzyme was noted to be elevated, consistent with non-st elevation mi.Two days later, the patient's coronary angiography revealed, 95% isr in proximal lcx and 80% stenosis in the mid lcx.The patient underwent coronary artery bypass graft including left internal mammary artery to lad, saphenous vein graph to obtuse marginal (om)1 and om2.On the same day, the patient was noted to have cardiogenic shock and an intra-aortic balloon pump inserted.Eight days after, the event was considered resolved and the patient was discharged.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8653980
• MDR Text Key: 146499617
• Report Number: 2134265-2019-05547
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/30/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 05/30/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR