MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT

Model Number H7493942832400

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

Patient Problems Cardiac Enzyme Elevation (1838); Hypoxia (1918); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/13/2021

Event Type  Death  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

Evolve_lv_xlv study.It was reported that death occurred.In (b)(6) 2021, the subject presented with myocardial infarction and was referred for cardiac catheterization.The target lesion was located in proximal right coronary artery (rca) with 80% stenosis and was 20 mm long with a distal vessel diameter of 4 mm.The target lesion was treated with pre-dilation and placement of 4.0 mm x 32 mm study stent and a 3.5 x 48 mm synergy stent in an overlapping fashion.Following post-dilation, residual stenosis was 0%.The next day, the subject was discharged on clopidogrel.In (b)(6) 2021, a staged procedure was performed.Non-target lesions from the left main coronary artery into the left circumflex artery (lcx) were treated using a 3.5 mm x 16 mm synergy megatron stent and a non-target lesion of the proximal lcx was treated using a 3.00 mm x 38 mm synergy stent in an overlapping fashion.During the staged procedure, the left anterior descending artery was successfully crossed into the diagonal branch and dilated with balloon angioplasty.The subject was noted to have a perforation in the diagonal branch which was initially managed with prolonged balloon inflation and subsequently pericardiocentesis was performed.The subject was noted to have ongoing extravasation from the diagonal branch which was treated with fat embolization.In (b)(6) 2021, the subject presented to the clinic with worsening dyspnea and stated they had passed out.The subject was noted to be on room air with saturation of 93%.The subject complained of an increase in baseline cough with hemoptysis and chest pain during deep breath.The subject was transferred to another hospital with hypoxia, elevated troponin, leg swelling, and concern for congestive heart failure (chf).The subject had fever, shortness of breath, cough and reported hemoptysis which appeared after being on dual antiplatelet along with anticoagulation for atrial fibrillation (historical).The subject was noted to be on eliquis and plavix, however aspirin was stopped a week prior.Eliquis was interrupted and the subject was placed on heparin drops.Hypoxia was possibly in the setting of acute chf and underlying pulmonary disease.The subject was diagnosed with acute hypoxemic respiratory failure likely combination of acute chf and possible pneumonia.The subject was treated aggressively for several days with lasix, a low sodium diet, high dose of steroids, broad spectrum antibiotics and diuretics along with continued fraction of inspired oxygen requirement.The subject had no improvement and following discussion with the pulmonology team and subject elected to be do not resuscitate.The subject was seen for possible transition to inpatient hospice.Seven days later, the patient died.No autopsy was performed.

Event Description

(b)(4) study.It was reported that death occurred.In (b)(6) 2021, the subject presented with myocardial infarction and was referred for cardiac catheterization.The target lesion was located in proximal right coronary artery (rca) with 80% stenosis and was 20 mm long with a distal vessel diameter of 4 mm.The target lesion was treated with pre-dilation and placement of 4.0 mm x 32 mm study stent and a 3.5 x 48 mm synergy stent in an overlapping fashion.Following post-dilation, residual stenosis was 0%.The next day, the subject was discharged on clopidogrel.In (b)(6) 2021, a staged procedure was performed.Non-target lesions from the left main coronary artery into the left circumflex artery (lcx) were treated using a 3.5 mm x 16 mm synergy megatron stent and a non-target lesion of the proximal lcx was treated using a 3.00 mm x 38 mm synergy stent in an overlapping fashion.During the staged procedure, the left anterior descending artery was successfully crossed into the diagonal branch and dilated with balloon angioplasty.The subject was noted to have a perforation in the diagonal branch which was initially managed with prolonged balloon inflation and subsequently pericardiocentesis was performed.The subject was noted to have ongoing extravasation from the diagonal branch which was treated with fat embolization.In (b)(6) 2021, the subject presented to the clinic with worsening dyspnea and stated they had passed out.The subject was noted to be on room air with saturation of 93%.The subject complained of an increase in baseline cough with hemoptysis and chest pain during deep breath.The subject was transferred to another hospital with hypoxia, elevated troponin, leg swelling, and concern for congestive heart failure (chf).The subject had fever, shortness of breath, cough and reported hemoptysis which appeared after being on dual antiplatelet along with anticoagulation for atrial fibrillation (historical).The subject was noted to be on eliquis and plavix, however aspirin was stopped a week prior.Eliquis was interrupted and the subject was placed on heparin drops.Hypoxia was possibly in the setting of acute chf and underlying pulmonary disease.The subject was diagnosed with acute hypoxemic respiratory failure likely combination of acute chf and possible pneumonia.The subject was treated aggressively for several days with lasix, a low sodium diet, high dose of steroids, broad spectrum antibiotics and diuretics along with continued fraction of inspired oxygen requirement.The subject had no improvement and following discussion with the pulmonology team and subject elected to be do not resuscitate.The subject was seen for possible transition to inpatient hospice.Seven days later, the patient died.No autopsy was performed.It was further reported that the on (b)(6) 2021, the subject underwent pcr and tma test for covid-19 and was found to be negative for sars-cov-2 (covid-19).On (b)(6) 2021, the subject passed away due to hypoxemic respiratory failure secondary to lung disease and autopsy was not performed.At the time of death, the subject was noted to be on eliquis, and plavix.The subject was noted with diagnosis of acute hypoxic respiratory failure due to probable interstitial lung disease, coronary artery disease, paroxysmal atrial fibrillation and orthostatic hypotension.

Manufacturer Narrative

A1 patient identifier: (b)(6).

• Brand Name: SYNERGY MEGATRON
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12139984
• MDR Text Key: 260663955
• Report Number: 2134265-2021-08758
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985785
• UDI-Public: 08714729985785
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2021
• Device Model Number: H7493942832400
• Device Lot Number: 0026510884
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR