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

Model Number 10622

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

Patient Problems Angina (1710); Reocclusion (1985); No Code Available (3191); Restenosis (4576)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

(b)(6) study.It was reported that the subject experienced unstable angina.In (b)(6) 2019, the subject was referred for cardiac catherization and four days after, the index procedure was performed.Target lesion #1 was located in the mid left anterior descending (lad) artery with 80% stenosis and was 25 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 x 28 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Target lesion #2 was located in the left main coronary artery (lmca) with 80% stenosis and was 29 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 32 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.The following day abnormal troponin increased after operation.Five days after, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2020, the subject presented with symptoms of angina pectoris and was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with the unstable angina pectoris.Two days later, the subject was referred for coronary angiography which revealed lad (target vessel) with 90% proximal stenosis which was treated with percutaneous coronary intervention (pci) (target vessel revascularization/tvr).Post intervention, residual stenosis was 0%.Three days later, the event was considered recovered/resolved and the subject was discharged on the same day.

Event Description

Same case as pr id# (b)(6).Synergy china registry study.It was reported that unstable angina occurred.In (b)(6) 2019, the patient was referred for cardiac catherization and four days after, index procedure was performed.The target lesion #1 was located in the mid left anterior descending (lad) artery with 80% stenosis and was 25 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 x 28 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.The target lesion #2 was located in the left main coronary artery (lmca) with 80% stenosis and was 29 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 32 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.The following day abnormal troponin increased after operation.Five days after, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2020, the patient presented with symptoms of angina pectoris and was hospitalized on the same day for further evaluation and treatment.The patient was diagnosed with the unstable angina pectoris.Two days later, the subject was referred for coronary angiography which revealed lad with 90% proximal stenosis was treated with pci (tvr).Post intervention, residual stenosis was 0%.Three days later, the event was considered recovered/resolved and the patient was discharged on the same day.It was further reported that target lesion #1 reference diameter was 2.25mm.Target lesion #2 was located in the lmca extending up to proximal lad with 60% stenosis.

Manufacturer Narrative

E1 initial reporter address 1: (b)(6).

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).

Event Description

Same case as pr id# (b)(4).Synergy china registry.It was reported that the subject experienced unstable angina.In (b)(6) 2019, the subject was referred for cardiac catheterization and four days after, the index procedure was performed.Target lesion #1 was located in the mid left anterior descending (lad) artery with 80% stenosis and was 25 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 x 28 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Target lesion #2 was located in the left main coronary artery (lmca) with 80% stenosis and was 29 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 32 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.The following day abnormal troponin increased after operation.Five days after, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2020, the subject presented with symptoms of angina pectoris and was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with the unstable angina pectoris.Two days later, the subject was referred for coronary angiography which revealed lad (target vessel) with 90% proximal stenosis which was treated with percutaneous coronary intervention (pci) (target vessel revascularization/tvr).Post intervention, residual stenosis was 0%.Three days later, the event was considered recovered/resolved and the subject was discharged on the same day.It was further reported that target lesion #1 reference diameter was 2.25mm.Target lesion #2 was located in the lmca extending up to proximal lad with 60% stenosis.It was further reported that in february 2021, the subject was diagnosed with unstable angina pectoris.The subject was hospitalized for further evaluation and treatment.No other action was taken to treat the event.Six days later, the subject was discharged on aspirin and ticagrelor.At the time of reporting, the event was recovering and resolving.The physician considers the study device is unlikely related to the event.

Event Description

Same case as pr id# (b)(4).Synergy china registry it was reported that the subject experienced unstable angina.In october 2019, the subject was referred for cardiac catheterization and four days after, the index procedure was performed.Target lesion #1 was located in the mid left anterior descending (lad) artery with 80% stenosis and was 25 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 x 28 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Target lesion #2 was located in the left main coronary artery (lmca) with 80% stenosis and was 29 mm long, with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 32 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.The following day abnormal troponin increased after operation.Five days after, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2020, the subject presented with symptoms of angina pectoris and was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with the unstable angina pectoris.Two days later, the subject was referred for coronary angiography which revealed lad (target vessel) with 90% proximal stenosis which was treated with percutaneous coronary intervention (pci) (target vessel revascularization/tvr).Post intervention, residual stenosis was 0%.Three days later, the event was considered recovered/resolved and the subject was discharged on the same day.It was further reported that target lesion #1 reference diameter was 2.25mm.Target lesion #2 was located in the lmca extending up to proximal lad with 60% stenosis.It was further reported that in (b)(6) 2021, the subject was diagnosed with unstable angina pectoris.The subject was hospitalized for further evaluation and treatment.No other action was taken to treat the event.Six days later, the subject was discharged on aspirin and ticagrelor.At the time of reporting, the event was recovering and resolving.The physician considers the study device is unlikely related to the event.It was further reported that in (b)(6) 2021, the subject was diagnosed with unstable angina pectoris and was hospitalized for further evaluation and treatment.A week and three days later, the subject was referred for coronary angiography which revealed 80% stenosis in mid lad extending up to distal lad which had previously placed study device.Medication was given to treat the event and coronary bypass graft (cabg) surgery was performed (tvr).Post intervention, residual stenosis was unknown.At the time of reporting, the event was recovering and resolving.Two weeks and three days later, the subject was discharged.The physician considers the study device is unlikely related to the event.

Manufacturer Narrative

B5.Describe event or problem- updated.D4: model number updated.D4: lot number - corrected from 23602806 to 23602808.D4: expiration date updated to 09/29/2020.D4: unique identifier (udi) # updated.E1 initial reporter address 1: (b)(6).

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10684593
• MDR Text Key: 211507830
• Report Number: 2134265-2020-14077
• 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,Followup,Followup
• Report Date: 07/20/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2020
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0023602808
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 10/20/2020; 05/31/2021; 06/30/2021
• Supplement Dates FDA Received: 11/12/2020; 06/22/2021; 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR