MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT

Model Number	H7493942832350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Obstruction/Occlusion (2422)
Date of Event	06/25/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
(b)(6).It was reported that abrupt closure, cardiac arrest, and patient death occurred.On (b)(6) 2021, the subject was enrolled in the study and the index procedure was performed.The 85% stenosed target lesion was located in the proximal left circumflex (lcx).The lesion was treated with predilatation and placement of a 3.50 mm x 32 mm study stent.Following post dilatation, residual stenosis was 0%.Post procedure abrupt closure was noted with timi flow of 3.However, no perforation and thrombus were noted.On (b)(6) 2021, the subject visited the hospital with symptoms related to cardiac arrest and was hospitalized on the same day.The subject underwent diagnostic test of echocardiogram and in response to the event, medications were given.Two days later, the subject passed away.
Additional Manufacturer Narrative
A1 patient identifier: (b)(6).
Event or Problem Description
Evolve_lv_xlv.It was reported that abrupt closure, cardiac arrest, and patient death occurred.On (b)(6) 2021, the subject was enrolled in the study and the index procedure was performed.The 85% stenosed target lesion was located in the proximal left circumflex (lcx).The lesion was treated with predilatation and placement of a 3.50 mm x 32 mm study stent.Following post dilatation, residual stenosis was 0%.Post procedure abrupt closure was noted with timi flow of 3.However, no perforation and thrombus were noted.On (b)(6) 2021, the subject visited the hospital with symptoms related to cardiac arrest and was hospitalized on the same day.The subject underwent diagnostic test of echocardiogram and in response to the event, medications were given.Two days later, the subject passed away.It was further reported that the target lesion was 20mm long with a reference diameter of 4.00mm.Post dilatation was performed using a 5mm balloon.Following the index procedure, the subject was discharged on clopidogrel.It was further noted that the subject died due to cardiac arrest with pulseless electric activity (pea).An autopsy was not performed, and a death certificate is not available.
Additional Manufacturer Narrative
A1 patient identifier: (b)(6).
Event or Problem Description
Evolve_lv_xlv.It was reported that abrupt closure, cardiac arrest, and patient death occurred.On (b)(6) 2021, the subject was enrolled in the study and the index procedure was performed.The 85% stenosed target lesion was located in the proximal left circumflex (lcx).The lesion was treated with predilatation and placement of a 3.50 mm x 32 mm study stent.Following post dilatation, residual stenosis was 0%.Post procedure abrupt closure was noted with timi flow of 3.However, no perforation and thrombus were noted.On (b)(6) 2021, the subject visited the hospital with symptoms related to cardiac arrest and was hospitalized on the same day.The subject underwent diagnostic test of echocardiogram and in response to the event, medications were given.Two days later, the subject passed away.It was further reported that the target lesion was 20mm long with a reference diameter of 4.00mm.Post dilatation was performed using a 5mm balloon.Following the index procedure, the subject was discharged on clopidogrel.It was further noted that the subject died due to cardiac arrest with pulseless electric activity (pea).An autopsy was not performed, and a death certificate is not available.It was further reported that on (b)(6) 2021, post dilation was performed using a 5mm balloon with maximum inflation pressure of 14mm.It was noted that the subject was on clopidogrel 75 mg at the time of event, and had been since on (b)(6) 2021.It was determined that the cause of death was not related to the study device.It was further reported that the abrupt closure occurred at an av groove circumflex branch that was covered by the study stent placed.There were multiple attempts to rewire this branch, but no other devices could cross into the side branch.It was determined after a lengthy attempt to end the procedure since the proximal portion of the circumflex was revascularized.Two days later the subject was brought back for a physiology fractional flow reserve (ffr) test of the left anterior descending artery (lad), which resulted in a negative value.The subject was discharged.The subject came back to the hospital with an non st elevation myocardial infarction (nstemi) cardiac arrest and passed away.It was noted this was out of proportion response caused by abrupt closure of a small side branch, which may or may not have been a major contributing factor to cardiac arrest.The study stent was not believed to have high correlation to the patient death.It was suspected that co morbidities more relevant to cardiac arrest was sustained ventricular tachycardia.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12204925
• Report Number: 2134265-2021-09357
• Device Sequence Number: 17207233
• Product Code: NIQ
• UDI-Device Identifier: 08714729985778
• UDI-Public: 08714729985778
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2021

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: 12/02/2021
• Device Model Number: H7493942832350
• Device Lot Number: 0026505660
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 07/28/2021; 08/10/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/11/2021; 09/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 62 YR