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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problems Angina (1710); Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Restenosis (4576)

Event Date 11/03/2023

Event Type  Injury  

Manufacturer Narrative

E1 : (b)(6) hospital.

Event Description

Agent ide study: it was reported that in-stent restenosis (isr) occurred.On (b)(6) 2022, the subject presented with angina and the 4.00 mm x 28 mm synergy megatron stent was implanted in the proximal right coronary artery (rca).On (b)(6) 2023, the subject presented to hospital with chief complaint of chest pain associated with coronary artery disease and hypertension.The subject also reported symptoms in the last two days and described it as right sided chest pain similar to previous angina.Cardiac catheterization on a later date was planned.On (b)(6) 2023, coronary angiography revealed 75% isr of the 4.00 mm x 28 mm synergy megatron stent implanted in the proximal rca and the subject was diagnosed with coronary artery disease.The 75% isr was treated with a 5.00 mm x 15 mm non-boston scientific (non-bsc) balloon.Post revascularization, the residual stenosis was noted as 20% with timi flow 3.On the same day, 75% isr of the mid rca was treated with a 4.00 mm x 30 mm non-bsc drug-eluting stent and followed by post dilation with a 4.50 noncompliant balloon.Post revascularization, the residual stenosis was noted as 0% with timi flow 3.The event was considered to be resolved/recovered.

Manufacturer Narrative

B3 date of event and d6a implant date: corrected e1 initial reporter facility name: lind(b)(6) hospital.

Event Description

Agent ide study it was reported that in-stent restenosis (isr) occurred.On (b)(6) 2022, the subject presented with angina and the 4.00 mm x 28 mm synergy megatron stent was implanted in the proximal right coronary artery (rca).On (b)(6) 2023, the subject presented to hospital with chief complaint of chest pain associated with coronary artery disease and hypertension.The subject also reported symptoms in the last two days and described it as right sided chest pain similar to previous angina.Cardiac catheterization on a later date was planned.On (b)(6) 2023, coronary angiography revealed 75% isr of the 4.00 mm x 28 mm synergy megatron stent implanted in the proximal rca and the subject was diagnosed with coronary artery disease.The 75% isr was treated with a 5.00 mm x 15 mm non-boston scientific (non-bsc) balloon.Post revascularization, the residual stenosis was noted as 20% with timi flow 3.On the same day, 75% isr of the mid rca was treated with a 4.00 mm x 30 mm non-bsc drug-eluting stent and followed by post dilation with a 4.5 noncompliant balloon.Post revascularization, the residual stenosis was noted as 0% with timi flow 3.The event was considered to be resolved/recovered.It was further reported that on (b)(6) 2022, the 4.00 mm x 28 mm synergy megatron and a 4.50 x 32 synergy xd stent were implanted in the proximal rca.On (b)(6) 2023, the subject was diagnosed with unstable angina and was hospitalized.At the time of the event the subject was on clopidogrel.The next day, the subject was discharged and was scheduled for cardiac catheterization on a later date.On (b)(6) 2024, the subject returned to the hospital for diagnostic coronary angiography.Angiography revealed 70% in-stent restenosis of the proximal rca previously treated with the 4.00 x 28 mm synergy megatron stent and the 4.50 x 32 mm synergy stent.Revascularization was recommended.The 70% in-stent restenosis at the proximal rca was initially pre-dilated with a 4.00 x 20 mm nc non-boston scientific (non-bsc) balloon and was followed by brachytherapy.An area of under-expansion was observed in the stented area of the proximal rca.The stented area was treated with a 4.00 x 20 mm nc non-bsc balloon.Post revascularization, 20% residual stenosis was noted with timi flow 3.The event was considered to be recovered/resolved.

• Brand Name: SYNERGY MEGATRON
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18268034
• MDR Text Key: 329739401
• Report Number: 2124215-2023-68830
• Device Sequence Number: 1
• Product Code: NIQ
• 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
• Report Date: 02/02/2024

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Race: White