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

Model Number	10621
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/09/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
(b)(6) clinical study.It was reported that the subject died.In (b)(6) 2020, clinical status assessment indicated that the subject qualifying condition was multivessel disease.Prior to the procedure, the subject was found to have indication of myocardial infarction and was referred for cardiac catheterization.The target lesion was located in the saphenous vein graft with 95% stenosis and was 48 mm long with reference vessel diameter of 4.5 mm.The target lesion was treated with pre-dilatation and placement of 4.50 mm x 28 mm and 4.50 mm x 20 mm study stents.Following post-dilatation, residual stenosis was 0%.On the next day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, the subject experienced cardiac arrest and was hospitalized on the same day.The following day, the subject was pronounced dead.
Event or Problem Description
Evolve 4.5-5.0 clinical study it was reported that the subject died.In (b)(6) 2020, clinical status assessment indicated that the subject qualifying condition was multivessel disease.Prior to the procedure, the subject was found to have indication of myocardial infarction and was referred for cardiac catheterization.The target lesion was located in the saphenous vein graft with 95% stenosis and was 48 mm long with reference vessel diameter of 4.5 mm.The target lesion was treated with pre-dilatation and placement of 4.50 mm x 28 mm and 4.50 mm x 20 mm study stents.Following post-dilatation, residual stenosis was 0%.On the next day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, the subject experienced cardiac arrest and was hospitalized on the same day.The following day, the subject was pronounced dead.It was further reported that per the paramedics, the subject was breathing with a palpable pulse on their arrival.However, suddenly the subject became unresponsive with loss of pulse and apnea.The subject was given with 5 administrations of intravenous epinephrine prior to arrival at the emergency department.On arrival, there was a palpable pulse but the subject was unresponsive to verbal or painful stimuli and had fixed and dilated pupils.The subject was resuscitated at the emergency department, receiving multiple round of epinephrine.The subject field airway device was then replaced with an endotracheal tube which greatly improved oxygen saturation.A chest x-ray and ct scans were performed.The subject was admitted to the intensive care unit for further evaluation and treatment.The subject received antibiotics, iv fluid, in addition to vasopressors, bicarb and attempts to correct hyperk on admission, but the subject remained unresponsive.It was planned to start the subject on hypothermia protocol.The subject become bradycardic on telemetry and had a pulseless electrical activity arrest for about 12 minutes with no return of spontaneous circulation.
Additional Manufacturer Narrative
(a1) patient identifier: (b)(6).B5 updated.
Event or Problem Description
Evolve 4.5-5.0 clinical study.It was reported that the subject died.In (b)(6) 2020, clinical status assessment indicated that the subject qualifying condition was multivessel disease.Prior to the procedure, the subject was found to have indication of myocardial infarction and was referred for cardiac catheterization.The target lesion was located in the saphenous vein graft with 95% stenosis and was 48 mm long with reference vessel diameter of 4.5 mm.The target lesion was treated with pre-dilatation and placement of 4.50 mm x 28 mm and 4.50 mm x 20 mm study stents.Following post-dilatation, residual stenosis was 0%.On the next day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, the subject experienced cardiac arrest and was hospitalized on the same day.The following day, the subject was pronounced dead.It was further reported that per the paramedics, the subject was breathing with a palpable pulse on their arrival.However, suddenly the subject became unresponsive with loss of pulse and apnea.The subject was given with 5 administrations of intravenous epinephrine prior to arrival at the emergency department.On arrival, there was a palpable pulse but the subject was unresponsive to verbal or painful stimuli and had fixed and dilated pupils.The subject was resuscitated at the emergency department, receiving multiple round of epinephrine.The subject field airway device was then replaced with an endotracheal tube which greatly improved oxygen saturation.A chest x-ray and ct scans were performed.The subject was admitted to the intensive care unit for further evaluation and treatment.The subject received antibiotics, iv fluid, in addition to vasopressors, bicarb and attempts to correct hyperk on admission, but the subject remained unresponsive.It was planned to start the subject on hypothermia protocol.The subject become bradycardic on telemetry and had a pulseless electrical activity arrest for about 12 minutes with no return of spontaneous circulation.It was further reported that in (b)(6) 2021, the subject was diagnosed with respiratory failure.It was further reported that as per death certificate, the immediate cause of death was respiratory failure and other underlying causes to be metabolic acidosis, cardiogenic shock and cardiac arrest.And other significant contributing to death but not resulting in the underlying cause was hyperkalemia.
Additional Manufacturer Narrative
(a1) patient identifier: (b)(6).(b5) describe event or problem updated.
Additional Manufacturer Narrative
(a1) patient identifier: (b)(6).(b5) describe event or problem updated.
Event or Problem Description
Evolve 4.5-5.0 clinical study it was reported that the subject died.In (b)(6) 2020, clinical status assessment indicated that the subject qualifying condition was multivessel disease.Prior to the procedure, the subject was found to have indication of myocardial infarction and was referred for cardiac catheterization.The target lesion was located in the saphenous vein graft with 95% stenosis and was 48 mm long with reference vessel diameter of 4.5 mm.The target lesion was treated with pre-dilatation and placement of 4.50 mm x 28 mm and 4.50 mm x 20 mm study stents.Following post-dilatation, residual stenosis was 0%.On the next day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, the subject experienced cardiac arrest and was hospitalized on the same day.The following day, the subject was pronounced dead.It was further reported that per the paramedics, the subject was breathing with a palpable pulse on their arrival.However, suddenly the subject became unresponsive with loss of pulse and apnea.The subject was given with 5 administrations of intravenous epinephrine prior to arrival at the emergency department.On arrival, there was a palpable pulse but the subject was unresponsive to verbal or painful stimuli and had fixed and dilated pupils.The subject was resuscitated at the emergency department, receiving multiple round of epinephrine.The subject field airway device was then replaced with an endotracheal tube which greatly improved oxygen saturation.A chest x-ray and ct scans were performed.The subject was admitted to the intensive care unit for further evaluation and treatment.The subject received antibiotics, iv fluid, in addition to vasopressors, bicarb and attempts to correct hyperk on admission, but the subject remained unresponsive.It was planned to start the subject on hypothermia protocol.The subject become bradycardic on telemetry and had a pulseless electrical activity arrest for about 12 minutes with no return of spontaneous circulation.It was further reported that in (b)(6) 2021, the subject was diagnosed with respiratory failure.It was further reported that as per death certificate, the immediate cause of death was respiratory failure and other underlying causes to be metabolic acidosis, cardiogenic shock and cardiac arrest.And other significant contributing to death but not resulting in the underlying cause was hyperkalemia.It was further reported that in (b)(6) 2021, the subject was presented to the emergency department out of hospital cardiac arrest.The ct of head revealed subdural hematoma and evidence of anoxic brain injury, and cardiac death occurred.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11328637
• Report Number: 2134265-2021-01192
• Device Sequence Number: 1151510
• Product Code: NIQ
• UDI-Device Identifier: 08714729973386
• UDI-Public: 08714729973386
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/27/2021

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: 10/06/2021
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0024604487
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 02/11/2021; 03/02/2021; 04/12/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 03/04/2021; 03/18/2021; 04/27/2021
• 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: Death
• Patient Age: 77 YR