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

Device Problems Defective Device (2588); Material Deformation (2976)

Patient Problems Death (1802); Thrombosis (2100); Cardiogenic Shock (2262)

Event Date 11/01/2018

Event Type  Death  

Manufacturer Narrative

Event date was not reported and approximated (b)(6) 2018.Device is combination product.

Event Description

It was reported there was suboptimal post-deployment strut alignment as well as the patient experienced thrombosis, cardiogenic shock and expired.A diagnostic catheterization was performed in (b)(6) 2018.The patient was believed to be a suboptimal candidate for a coronary artery bypass graft (cabg) & surgical aortic valve replacement (savr) and had considerable comorbidities & frailty.The patients symptoms were initially managed medically but due to some progression in symptoms, the primary care provider (pcp) requested valve committee re-evaluate the patient.The valve committee decided percutaneous coronary intervention (pci) to the right coronary artery (rca) and the left circumflex (lcx) should be performed prior to having a transcatheter aortic valve replacement (tavr) due to severe obstructive coronary artery disease (cad).(b)(6) 2018 - the patient underwent a pci procedure via left radial approach using a 6f amplatz r1 guide catheter.A guidewire was advanced into the rca and a 1.5x20 balloon was advanced but was unable to be advanced distal to the mid rca.The guidewire was exchanged and brilinta was administered.It was noted the activated clotting time (act) was 295.The physician performed multiple attempts to open the rca using orbital atherectomy and dilation with multiple balloons unsuccessfully.The physician decided to perform four additional runs using orbital atherectomy in the mid rca and was finally able to successfully implant a synergy drug coated stent.However; no reflow was noted.The patient's heart rate was noted to be 40 bpm & blood pressure was 60systolic.The patient became unresponsive with deep vein thrombosis noted and a intra-aortic balloon pump (iabp) was placed.The patient was intubated and cardiopulmonary resuscitation (cpr) was administered.The patient went in to cardiogenic shock and after prolonged cpr the family requested to withdraw care and the patient expired.

Event Description

It was reported there was suboptimal post-deployment strut alignment as well as the patient experienced thrombosis, cardiogenic shock and expired.A diagnostic catheterization was performed in (b)(6) 2018.The patient was believed to be a suboptimal candidate for a coronary artery bypass graft (cabg) & surgical aortic valve replacement (savr) and had considerable comorbidities & frailty.The patients symptoms were initially managed medically but due to some progression in symptoms, the primary care provider (pcp) requested valve committee re-evaluate the patient.The valve committee decided percutaneous coronary intervention (pci) to the right coronary artery (rca) and the left circumflex (lcx) should be performed prior to having a transcatheter aortic valve replacement (tavr) due to severe obstructive coronary artery disease (cad).On (b)(6) 2018: the patient underwent a pci procedure via left radial approach using a 6f amplatz r1 guide catheter.A guidewire was advanced into the rca and a 1.5x20 balloon was advanced but was unable to be advanced distal to the mid rca.The guidewire was exchanged and brilinta was administered.It was noted the activated clotting time (act) was 295.The physician performed multiple attempts to open the rca using orbital atherectomy and dilation with multiple balloons unsuccessfully.The physician decided to perform four additional runs using orbital atherectomy in the mid rca and was finally able to successfully implant a synergy drug coated stent.However; no reflow was noted.The patient's heart rate was noted to be 40 bpm & blood pressure was 60systolic.The patient became unresponsive with deep vein thrombosis noted and a intra-aortic balloon pump (iabp) was placed.The patient was intubated and cardiopulmonary resuscitation (cpr) was administered.The patient went in to cardiogenic shock and after prolonged cpr the family requested to withdraw care and the patient expired.It was further reported there was no stent damage post deployment as previously reported.The physician also has stated that in his opinion the stent did not cause or contribute to the patients death.It has been noted the patients death was caused by cardiogenic shock.

Manufacturer Narrative

Event date was not reported and approximated (b)(6) 2018.Device is combination product.Adverse event/product problem: previously reported as adverse event/product problem has been corrected to adverse event.Device codes: previously reported as material deformation 2976 has been corrected to defective device 2588.Medical review of media performed.The images provided are consistent with pci to a severely calcified mid rca.The lesion was only dilatable after preparation with orbital atherectomy.No reflow resulting in severe hemodynamic collapse followed synergy stent deployment.Patient hemodynamics were supported with intra-aortic balloon counterpulsation and transvenous pacing.Vessel dissection, distal microembolization or suboptimal stent strut alignment may have contributed to the flow reduction.The case concluded with balloon aortic valvuloplasty indicating aortic stenosis may have contributed as well.Vessel damage, suboptimal stent strut apposition, reduced distal flow, heart block and hypotension (shock) are included in the synergy risk management documentation.

• 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: 8289238
• MDR Text Key: 134487712
• Report Number: 2134265-2019-00554
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR