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

Model Number	10601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiopulmonary Arrest (1765); Death (1802)
Date of Event	02/25/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
(b)(6) clinical study.It was reported that the subject had cardio-respiratory arrest and died.In (b)(6) 2018, the subject presented with unstable angina and was further referred for elective cardiac catheterization.The index procedure was performed on the same day.The target lesion was in the proximal left anterior circumflex (lcx) artery with 95% stenosis, 7mm long with a reference vessel diameter of 3.5mm.The lesion was treated with pre-dilatation and placement of a 3.50x12mm study stent.Following post-dilatation, residual stenosis was 0%.The patient was discharged the same day on dual anti-platelet therapy.In (b)(6) 2019, 385 days post index procedure, the subject presented to the emergency department intubated after suffering a cardiac arrest.The arrest was likely primary respiratory with secondary cardiac.The subject was placed with central line for vascular access.The subject was initially found in asystole and achieved return of spontaneous circulation after epinephrine administration and 4 rounds of compressions.Multiple electrocardiography (ecg) testing was performed along with computed tomography angiography (cta), echocardiogram and chest x rays.The subject was also noted to have bleeding from nasogastric tube and was diagnosed with gastro-intestinal bleeding and was transfused with 2 units of red blood cells.During hospitalization, the subject was noted with septic shock, leukocytosis, pulmonary embolism and transaminitis.On the same day, aspirin and plavix was kept on hold.After three days, the patient was hemodynamically unstable in the intensive care unit.On the same day, the subject was extubated and expired.
Additional Manufacturer Narrative
Device is a combination product.Updated describe event or problem and other relevant history.
Event or Problem Description
Evolve short dapt clinical study.It was reported that the patient had cardio-respiratory arrest and died.In (b)(6) 2018, the patient presented with unstable angina and was further referred for elective cardiac catheterization.The index procedure was performed on the same day.The target lesion was in the proximal left anterior circumflex (lcx) artery with 95% stenosis, 7mm long with a reference vessel diameter of 3.5mm.The lesion was treated with pre-dilatation and placement of a 3.50x12mm study stent.Following post-dilatation, residual stenosis was 0%.The patient was discharged the same day on dual anti-platelet therapy.In (b)(6) 2019, 385 days post index procedure, the patient presented to the emergency department intubated after suffering a cardiac arrest.The arrest was likely primary respiratory with secondary cardiac.The patient was placed with central line for vascular access.The patient was initially found in asystole and achieved return of spontaneous circulation after epinephrine administration and 4 rounds of compressions.Multiple electrocardiography (ecg) testing was performed along with computed tomography angiography (cta), echocardiogram and chest x rays.The patient was also noted to have bleeding from nasogastric tube and was diagnosed with gastro-intestinal bleeding and was transfused with 2 units of red blood cells.During hospitalization, the patient was noted with septic shock, leukocytosis, pulmonary embolism and transaminitis.On the same day, aspirin and plavix was kept on hold.After three days, the patient was hemodynamically unstable in the intensive care unit.On the same day, the patient was extubated and expired.It was further that on (b)(6) 2018, the patient was discharged on aspirin and clopidogrel therapy.In (b)(6) 2019, the patient went into pulseless electrical activity and then sinus tachycardia.The cause of death was cardio respiratory arrest.The patient was diagnosed by neurologist with anoxic ischemic encephalopathy without brainstem reflexes.

• 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: 8649943
• Report Number: 2134265-2019-05526
• Device Sequence Number: 19354614
• Product Code: NIQ
• UDI-Device Identifier: 08714729840060
• UDI-Public: 08714729840060
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2018
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0020860561
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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