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

Model Number H7493942824400

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

Patient Problems Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2021

Event Type  Death  

Event Description

Evolve lv xlv study it was reported that a patient death occurred.On (b)(6) 2021, the subject presented with stable angina and the index procedure was performed on the same day.The 90% stenosed target lesion as located in the mid right coronary artery (rca) and was 16mm long, with a reference vessel diameter of 4mm.The lesion was treated with predilation and placement of 4.00mm x 24mm and 4.00mm x 28mm study stents.Following post dilatation, residual stenosis was 0%.Non target lesions were also treated.The ramus lesion was treated with the placement of a 2.50mm x 24mm synergy stent.On the same day, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2021, a staged procedure was performed.The non target lesion located in the proximal left anterior descending artery (lad) and mid lad were treated using 3.00mm x 38mm synergy and 3.50mm x 32mm synergy stents in an overlapping fashion.On (b)(6) 2021, the subject expired due to unknown cause outside the hospital.In response to the event, no action or diagnostics were performed.It is unknown whether an autopsy was performed.

Event Description

Evolve lv xlv study it was reported that a patient death occurred.On( b)(6) 2021, the subject presented with stable angina and the index procedure was performed on the same day.The 90% stenosed target lesion as located in the mid right coronary artery (rca) and was 16mm long, with a reference vessel diameter of 4mm.The lesion was treated with predilation and placement of 4.00mm x 24mm and 4.00mm x 28mm study stents.Following post dilatation, residual stenosis was 0%.Non target lesions were also treated.The ramus lesion was treated with the placement of a 2.50mm x 24mm synergy stent.On the same day, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2021, a staged procedure was performed.The non target lesion located in the proximal left anterior descending artery (lad) and mid lad were treated using 3.00mm x 38mm synergy and 3.50mm x 32mm synergy stents in an overlapping fashion.On (b)(6) 2021, the subject expired due to unknown cause outside the hospital.In response to the event, no action or diagnostics were performed.It is unknown whether an autopsy was performed.It was further reported that the patient passed away at home.

Manufacturer Narrative

A1 patient identifier: (b)(6).Correction: h6: evaluation code: from: cause not established d15.To: known inherent risk of device d12.

Event Description

Evolve lv xlv study.It was reported that a patient death occurred.On (b)(6) 2021, the subject presented with stable angina and the index procedure was performed on the same day.The 90% stenosed target lesion as located in the mid right coronary artery (rca) and was 16mm long, with a reference vessel diameter of 4mm.The lesion was treated with predilation and placement of 4.00mm x 24mm and 4.00mm x 28mm study stents.Following post dilatation, residual stenosis was 0%.Non target lesions were also treated.The ramus lesion was treated with the placement of a 2.50mm x 24mm synergy stent.On the same day, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2021, a staged procedure was performed.The non target lesion located in the proximal left anterior descending artery (lad) and mid lad were treated using 3.00mm x 38mm synergy and 3.50mm x 32mm synergy stents in an overlapping fashion.On (b)(6) 2021, the subject expired due to unknown cause outside the hospital.In response to the event, no action or diagnostics were performed.It is unknown whether an autopsy was performed.It was further reported that the patient passed away at home.It was further reported that the cause of death was due to cardiac arrest, and it was corrected that the patient did not pass away at home.

Manufacturer Narrative

A1 patient identifier: (b)(6).

Event Description

Evolve lv xlv study.It was reported that a patient death occurred.On (b)(6) 2021, the subject presented with stable angina and the index procedure was performed on the same day.The 90% stenosed target lesion as located in the mid right coronary artery (rca) and was 16mm long, with a reference vessel diameter of 4mm.The lesion was treated with predilation and placement of 4.00mm x 24mm and 4.00mm x 28mm study stents.Following post dilatation, residual stenosis was 0%.Non target lesions were also treated.The ramus lesion was treated with the placement of a 2.50mm x 24mm synergy stent.On the same day, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2021, a staged procedure was performed.The non target lesion located in the proximal left anterior descending artery (lad) and mid lad were treated using 3.00mm x 38mm synergy and 3.50mm x 32mm synergy stents in an overlapping fashion.On 10 december 2021, the subject expired due to unknown cause outside the hospital.In response to the event, no action or diagnostics were performed.It is unknown whether an autopsy was performed.It was further reported that the patient passed away at home.It was further reported that the cause of death was due to cardiac arrest, and it was corrected that the patient did not pass away at home.

• Brand Name: SYNERGY MEGATRON
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13087787
• MDR Text Key: 282776802
• Report Number: 2134265-2021-16105
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729985709
• UDI-Public: 08714729985709
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: H7493942824400
• Device Lot Number: 0026480719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Race: White