Model Number 10606 |
Device Problems
Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiopulmonary Arrest (1765); Death (1802); Thrombosis (2100)
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Event Date 04/29/2019 |
Event Type
Death
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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(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 24 mm long with a reference vessel diameter of 3.00 mm.The target lesion was treated with direct placement of a 3.00 x 38 mm 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 56 mm long with a reference vessel diameter of 2.75 mm.The target lesion was treated with direct placement of 2.75 x 38 mm and 2.75 x 32 mm 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.
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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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 was further reported that at the time of event, the patient was on aspirin and clopidogrel.
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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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, residual 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.
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