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

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

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 01/15/2020

Event Type  Death  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that a patient expired.An elective coronary angioplasty was performed.The target lesion area was located in the left trunk of the ostium.An opticross vascular imaging catheter was selected for use.During preparation, it was noted to be kinked when connecting to the pullback sled.It was exchanged for another opticross catheter with the same lot number.Intravascular ultrasound (ivus) route was done with no complication.They decided to perform surgical myocardial revascularization based on the findings from the ivus.Minutes after removal of the opticross catheter, the patient started to decompensate.They became hypotensive and experienced bradycardia.They also had a cardiorespiratory arrest.The physician performs coronary angiography and a total occlusion of the distal third of the left coronary is found.An intraluminal thrombus was noticed in the left trunk ostium.In response, they implanted synergy stents 3.00x38mm in the distal third of the previous anterior descending predilatation and a 3.00x20mm in the left trunk proximal third of the previous descending.Both were inflated at 16 atm.The two synergy stents were implanted successfully.However, the patient never stabilized.Multiple episodes of ventricular tachycardia were manifested by the patient.Therefore, the patient receives ventilatory assistance and external cardiac massage and defibrillates four times with 200/300 joules, leaving at the rate of ventricular fibrillation.Then advanced cardiopulmonary resuscitation (cpr) with cardiac massage was performed.Orotracheal intubation and ventilation with 100% oxygen is given.1mg of adrenaline every two minutes up to a dose of 7 mg is administered sequentially.In addition, atropine 1mg was given, along with amiodarone bolus of 300mg and vasoactive start with norepinephrine.The patient continues in ventricular fibrillation despite multiple defibrillations (10) with 300 joules without success.25 minutes after starting the resuscitation efforts, the patient died.

Event Description

It was reported that a patient expired.An elective coronary angioplasty was performed.The target lesion area was located in the left trunk of the ostium.An opticross vascular imaging catheter was selected for use.During preparation, it was noted to be kinked when connecting to the pullback sled.It was exchanged for another opticross catheter with the same lot number.Intravascular ultrasound (ivus) route was done with no complication.They decided to perform surgical myocardial revascularization based on the findings from the ivus.Minutes after removal of the opticross catheter, the patient started to decompensate.They became hypotensive and experienced bradycardia.They also had a cardiorespiratory arrest.The physician performs coronary angiography and a total occlusion of the distal third of the left coronary is found.An intraluminal thrombus was noticed in the left trunk ostium.In response, they implanted synergy stents 3.00x38mm in the distal third of the previous anterior descending predilatation and a 3.00x20mm in the left trunk proximal third of the previous descending.Both were inflated at 16 atm.The two synergy stents were implanted successfully.However, the patient never stabilized.Multiple episodes of ventricular tachycardia were manifested by the patient.Therefore, the patient receives ventilatory assistance and external cardiac massage and defibrillates four times with 200/300 joules, leaving at the rate of ventricular fibrillation.Then advanced cardiopulmonary resuscitation (cpr) with cardiac massage was performed.Orotracheal intubation and ventilation with 100% oxygen is given.1mg of adrenaline every two minutes up to a dose of 7 mg is administered sequentially.In addition, atropine 1mg was given, along with amiodarone bolus of 300mg and vasoactive start with norepinephrine.The patient continues in ventricular fibrillation despite multiple defibrillations (10) with 300 joules without success.25 minutes after starting the resuscitation efforts, the patient died.The device was not returned for analysis.There was no evidence that the device was used in a manner inconsistent with the labelled indications.This product investigation is assigned the most probable cause classification of adverse event related to patient condition.This probable cause was selected since after removal of the opti cross catheter, the patient started to decompensate.The physician performs coronary angiography and an intraluminal thrombus was noticed in the left trunk ostium and in response, they implanted synergy stents successfully.However, the patient never stabilized.The patient continues in ventricular fibrillation despite multiple defibrillations without success and 25 minutes after starting the resuscitation efforts, the patient died.

Manufacturer Narrative

Device is a combination product.H6: evaluation conclusion code corrected.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9667111
• MDR Text Key: 177665865
• Report Number: 2134265-2020-00897
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR