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

Model Number	10607
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiopulmonary Arrest (1765); Death (1802); Thrombosis (2100)
Date of Event	04/29/2019
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 patient died.In (b)(6) 2018, the patient was referred for elective cardiac catheterization and the index procedure was performed on the same day.The target lesion #1 was located in the proximal left circumflex (lcx) artery with 80% stenosis and was 24mm long with a reference vessel diameter of 3.00 mm.The target lesion was treated with direct placement of a 3.00x38mm study stent.Following post dilatation, residual stenosis was 0% with timi 3 flow.The target lesion #2 was a long lesion extending from proximal right coronary artery (rca) to mid rca with 80% stenosis and was 56mm long with a reference vessel diameter of 2.75mm.The target lesion was treated with direct placement of 2.75x38mm and 2.75x32mm study stents.Following post dilatation, residua stenosis was 0% with timi 3 flow.Post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2019, the patient was brought to the emergency room via emergency medical services.The patient was found to be unresponsive, pulseless and apneic.The patient was also noted to have shortness of breath.On arrival to emergency department, electrocardiogram (ekg) revealed asystole cardiac rhythm and lab investigation revealed elevated troponin with the value 0.846 ng/ml (uln: 0.056 ng/ml).Physical examination revealed patient was cool to touch but not cold, no evidence of lividity and rigor mortis were noted, and pupils were dilated and fixed.Subsequently, endotracheal tube was placed for the management of the symptoms.On further examination, blood pressure was 153/66, heart rate was 81 and ventricular tachycardia was noted.The precordial thump was started in response to pulseless ventricular tachycardia and subject gave response but lost the pulse again.Amiodorone was initiated, cardiopulmonary resuscitation (cpr) was given and spontaneous circulation (rosc) was detected, however reports could not be obtained.On the same day, the patient died due to cardiopulmonary arrest.A death certificate is not available and an autopsy was not performed.
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
Evolve short dapt clinical study.It was reported that the patient died.In (b)(6) 2018, the patient was referred for elective cardiac catheterization and the index procedure was performed on the same day.The target lesion #1 was located in the proximal left circumflex (lcx) artery with 80% stenosis and was 24mm long with a reference vessel diameter of 3.00 mm.The target lesion was treated with direct placement of a 3.00x38mm study stent.Following post dilatation, residual stenosis was 0% with timi 3 flow.The target lesion #2 was a long lesion extending from proximal right coronary artery (rca) to mid rca with 80% stenosis and was 56mm long with a reference vessel diameter of 2.75mm.The target lesion was treated with direct placement of 2.75x38mm and 2.75x32mm study stents.Following post dilatation, residua stenosis was 0% with timi 3 flow.Post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2019, the patient was brought to the emergency room via emergency medical services.The patient was found to be unresponsive, pulseless and apneic.The patient was also noted to have shortness of breath.On arrival to emergency department, electrocardiogram (ekg) revealed asystole cardiac rhythm and lab investigation revealed elevated troponin with the value 0.846 ng/ml (uln: 0.056 ng/ml).Physical examination revealed patient was cool to touch but not cold, no evidence of lividity and rigor mortis were noted, and pupils were dilated and fixed.Subsequently, endotracheal tube was placed for the management of the symptoms.On further examination, blood pressure was 153/66, heart rate was 81 and ventricular tachycardia was noted.The precordial thump was started in response to pulseless ventricular tachycardia and subject gave response but lost the pulse again.Amiodorone was initiated, cardiopulmonary resuscitation (cpr) was given and spontaneous circulation (rosc) was detected, however reports could not be obtained.On the same day, the patient died due to cardiopulmonary arrest.A death certificate is not available and an autopsy was not performed.It as further reported that at the time of event, the patient was on aspirin and clopidogrel.
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
Evolve short dapt clinical study it was reported that the patient died.In (b)(6) 2018, the patient was referred for elective cardiac catheterization and the index procedure was performed on the same day.The target lesion #1 was located in the proximal left circumflex (lcx) artery with 80% stenosis and was 24mm long with a reference vessel diameter of 3.00 mm.The target lesion was treated with direct placement of a 3.00x38mm study stent.Following post dilatation, residual stenosis was 0% with timi 3 flow.The target lesion #2 was a long lesion extending from proximal right coronary artery (rca) to mid rca with 80% stenosis and was 56mm long with a reference vessel diameter of 2.75mm.The target lesion was treated with direct placement of 2.75x38mm and 2.75x32mm study stents.Following post dilatation, residua stenosis was 0% with timi 3 flow.Post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2019, the patient was brought to the emergency room via emergency medical services.The patient was found to be unresponsive, pulseless and apneic.The patient was also noted to have shortness of breath.On arrival to emergency department, electrocardiogram (ekg) revealed asystole cardiac rhythm and lab investigation revealed elevated troponin with the value 0.846 ng/ml (uln: 0.056 ng/ml).Physical examination revealed patient was cool to touch but not cold, no evidence of lividity and rigor mortis were noted, and pupils were dilated and fixed.Subsequently, endotracheal tube was placed for the management of the symptoms.On further examination, blood pressure was 153/66, heart rate was 81 and ventricular tachycardia was noted.The precordial thump was started in response to pulseless ventricular tachycardia and subject gave response but lost the pulse again."amiodarone" was initiated, cardiopulmonary resuscitation (cpr) was given and spontaneous circulation (rosc) was detected, however reports could not be obtained.On the same day, the patient died due to cardiopulmonary arrest.A death certificate is not available and an autopsy was not performed.It was further reported that at the time of event, the patient was on aspirin and clopidogrel.It was also reported that stent thrombosis occurred per adjudication.

• 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: 8668992
• Report Number: 2134265-2019-05841
• Device Sequence Number: 14018198
• Product Code: NIQ
• UDI-Device Identifier: 08714729840404
• UDI-Public: 08714729840404
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 08/15/2019

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: 11/08/2018
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0021426224
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/04/2019; 07/26/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 06/27/2019; 08/15/2019
• 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: 62 YR