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

Model Number 10605

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Contusion (1763); Chest Pain (1776); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Occlusion (1984); Reocclusion (1985); Thrombosis (2100)

Event Date 08/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device is a combination product.

Event Description

(b)(4) clinical study.It was reported that restenosis and myocardial infarction occurred.In (b)(6) 2017, patient clinical status assessement indicated the patient qualifying condition as unstable angina.The patient was referred for elective cardiac catheterization and index procedure was performed.The target lesion was located in 1st diagonal branch with 75% stenosis and was 22 mm long with a reference vessel diameter of 2.5 mm.The target lesion was treated with predilatation and placement of a 2.50 x 28 mm synergy stent with 0% residual stenosis.On the next day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient presented to emergency department via emergency medical services (ems) with intermittent anterior chest pain associated with shortness of breath and diaphoresis lasting from past two weeks.Prior to ems arrival, the patient had intense pain of scale 12/10 which was located in the middle of his chest and it radiates into his back and worsens on exertion.The patient took 3 baby aspirin and sub-lingual nitroglycerin at home.Post medication, the pain resolved to 4/10.Patient was hospitalized for further evaluation and treatment.Electrocardiogram (ecg) was abnormal and revealed increased ventricular rate by 3 beats per minute.Lung perfusion scan was performed revealed chronic obstructive pulmonary disease and low probability of pulmonary embolism.On the following day the patient was recommended for hemodialysis due to end stage renal disease.Computed tomography angiogram of the chest revealed, no evidence of aortic aneurysm or dissection.However, there was a small right effusion with many coronary artery calcifications, minimal peripheral reticulation of the right lung and enlargement of the pulmonary arteries noted.Two days after, the patient's cardiac enzyme was found to be elevated (peak troponin i: 718 ng/l; uln: 16 ng/l) consistent with protocol definition of myocardial infarction.On the following day, repeat ecg revealed atrial sensed ventricular paced rhythm with no significant changes from the previous ecgs and coronary angiography was performed which revealed 99% ostial stenosis in the 1st diagonal branch.On the same day, the 99% ostial stenosis located in 1st diagonal was treated with predilation and placement of 2.75 x 12 mm promus drug eluting stent with 0% residual stenosis and timi 3 flow.The next day, the event was considered resolved and the patient was discharged from the hospital.

Event Description

Evolve short dapt clinical study.It was reported that restenosis and myocardial infarction occurred.In (b)(6) 2017, patient clinical status assessement indicated the patient qualifying condition as unstable angina.The patient was referred for elective cardiac catheterization and index procedure was performed.The target lesion was located in 1st diagonal branch with 75% stenosis and was 22 mm long with a reference vessel diameter of 2.5 mm.The target lesion was treated with predilatation and placement of a 2.50 x 28 mm synergy stent with 0% residual stenosis.On the next day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient presented to emergency department via emergency medical services (ems) with intermittent anterior chest pain associated with shortness of breath and diaphoresis lasting from past two weeks.Prior to ems arrival, the patient had intense pain of scale 12/10 which was located in the middle of his chest and it radiates into his back and worsens on exertion.The patient took 3 baby aspirin and sub-lingual nitroglycerin at home.Post medication, the pain resolved to 4/10.Patient was hospitalized for further evaluation and treatment.Electrocardiogram (ecg) was abnormal and revealed increased ventricular rate by 3 beats per minute.Lung perfusion scan was performed revealed chronic obstructive pulmonary disease and low probability of pulmonary embolism.On the following day the patient was recommended for hemodialysis due to end stage renal disease.Computed tomography angiogram of the chest revealed, no evidence of aortic aneurysm or dissection.However, there was a small right effusion with many coronary artery calcifications, minimal peripheral reticulation of the right lung and enlargement of the pulmonary arteries noted.Two days after, the patient's cardiac enzyme was found to be elevated (peak troponin i: 718 ng/l; uln: 16 ng/l) consistent with protocol definition of myocardial infarction.On the following day, repeat ecg revealed atrial sensed ventricular paced rhythm with no significant changes from the previous ecgs and coronary angiography was performed which revealed 99% ostial stenosis in the 1st diagonal branch.On the same day, the 99% ostial stenosis located in 1st diagonal was treated with predilation and placement of 2.75 x 12 mm promus drug eluting stent with 0% residual stenosis and timi 3 flow.The next day, the event was considered resolved and the patient was discharged from the hospital.

Manufacturer Narrative

2134265-2018-64204: (b)(6).Device is a combination product.Adverse event/product problem - change from adverse event and product problem to adverse event.

Event Description

Evolve short dapt clinical study.It was reported that restenosis and myocardial infarction occurred.In (b)(6) 2017, patient clinical status assessement indicated the patient qualifying condition as unstable angina.The patient was referred for elective cardiac catheterization and index procedure was performed.The target lesion was located in 1st diagonal branch with 75% stenosis and was 22 mm long with a reference vessel diameter of 2.5 mm.The target lesion was treated with predilatation and placement of a 2.50 x 28 mm synergy stent with 0% residual stenosis.On the next day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient presented to emergency department via emergency medical services (ems) with intermittent anterior chest pain associated with shortness of breath and diaphoresis lasting from past two weeks.Prior to ems arrival, the patient had intense pain of scale (b)(6) which was located in the middle of his chest and it radiates into his back and worsens on exertion.The patient took 3 baby aspirin and sub-lingual nitroglycerin at home.Post medication, the pain resolved to (b)(6).Patient was hospitalized for further evaluation and treatment.Electrocardiogram (ecg) was abnormal and revealed increased ventricular rate by 3 beats per minute.Lung perfusion scan was performed revealed chronic obstructive pulmonary disease and low probability of pulmonary embolism.On the following day the patient was recommended for hemodialysis due to end stage renal disease.Computed tomography angiogram of the chest revealed, no evidence of aortic aneurysm or dissection.However, there was a small right effusion with many coronary artery calcifications, minimal peripheral reticulation of the right lung and enlargement of the pulmonary arteries noted.Two days after, the patient's cardiac enzyme was found to be elevated (peak troponin i: 718 ng/l; uln: 16 ng/l) consistent with protocol definition of myocardial infarction.On the following day, repeat ecg revealed atrial sensed ventricular paced rhythm with no significant changes from the previous ecgs and coronary angiography was performed which revealed 99% ostial stenosis in the 1st diagonal branch.On the same day, the 99% ostial stenosis located in 1st diagonal was treated with predilation and placement of 2.75 x 12 mm promus drug eluting stent with 0% residual stenosis and timi 3 flow.The next day, the event was considered resolved and the patient was discharged from the hospital.It was further reported that the placement of the 2.75 x 12 mm promus drug eluting stent in (b)(6) 2018 was placed in an overlapping fashion with the proximal portion of prior study stent.The study stent was patent with no evidence of in-stent restenosis.However, thrombotic occlusion of the 1st diagonal was noted proximal to the study stent.

Manufacturer Narrative

(b)(6).Device is a combination product.Adverse event/product problem - change from adverse event and product problem to adverse event.

Manufacturer Narrative

Initial reporter address 1: (b)(6).Device is a combination product.Adverse event/product problem change from adverse event and product problem to adverse event.

Event Description

Evolve short dapt clinical study.It was reported that restenosis and myocardial infarction occurred in december 2017, patient clinical status assessement indicated the patient qualifying condition as unstable angina.The patient was referred for elective cardiac catheterization and index procedure was performed.The target lesion was located in 1st diagonal branch with 75% stenosis and was 22 mm long with a reference vessel diameter of 2.5 mm.The target lesion was treated with predilatation and placement of a 2.50 x 28 mm synergy stent with 0% residual stenosis.On the next day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient presented to emergency department via emergency medical services (ems) with intermittent anterior chest pain associated with shortness of breath and diaphoresis lasting from past two weeks.Prior to ems arrival, the patient had intense pain of scale 12/10 which was located in the middle of his chest and it radiates into his back and worsens on exertion.The patient took 3 baby aspirin and sub-lingual nitroglycerin at home.Post medication, the pain resolved to 4/10.Patient was hospitalized for further evaluation and treatment.Electrocardiogram (ecg) was abnormal and revealed increased ventricular rate by 3 beats per minute.Lung perfusion scan was performed revealed chronic obstructive pulmonary disease and low probability of pulmonary embolism.On the following day the patient was recommended for hemodialysis due to end stage renal disease.Computed tomography angiogram of the chest revealed, no evidence of aortic aneurysm or dissection.However, there was a small right effusion with many coronary artery calcifications, minimal peripheral reticulation of the right lung and enlargement of the pulmonary arteries noted.Two days after, the patient's cardiac enzyme was found to be elevated (peak troponin i: 718 ng/l; uln: 16 ng/l) consistent with protocol definition of myocardial infarction.On the following day, repeat ecg revealed atrial sensed ventricular paced rhythm with no significant changes from the previous ecgs and coronary angiography was performed which revealed 99% ostial stenosis in the 1st diagonal branch.On the same day, the 99% ostial stenosis located in 1st diagonal was treated with predilation and placement of 2.75 x 12 mm promus drug eluting stent with 0% residual stenosis and timi 3 flow.The next day, the event was considered resolved and the patient was discharged from the hospital.It was further reported that the placement of the 2.75 x 12 mm promus drug eluting stent in august 2018 was placed in an overlapping fashion with the proximal portion of prior study stent.The study stent was patent with no evidence of in-stent restenosis.However, thrombotic occlusion of the 1st diagonal was noted proximal to the study stent.It was further reported that stent thrombosis occured as per adjudication.

• 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
• MDR Report Key: 8180251
• MDR Text Key: 130888042
• Report Number: 2134265-2018-64204
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840275
• UDI-Public: 08714729840275
• Combination Product (y/n): N
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2018
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0020686875
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR