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

Model Number 10621

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

Patient Problems Angina (1710); Restenosis (4576)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: (b)(6).

Event Description

(b)(6) registry.It was reported that unstable angina occurred.In (b)(6) 2020, the subject presented with unstable angina and was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion #1 was located in the proximal left anterior descending artery (lad) extending up to mid lad with 99% stenosis and was 46 mm long and a reference vessel diameter of 3.00 mm.The target lesion #1 was treated with pre-dilatation and placement of a 2.50 mm x 24 mm overlapped with 3.00 mm x 28 mm synergy china stent system.Following this, the post dilatation was not performed.Post procedural residual stenosis was 0%.Two days later, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2021, the subject was diagnosed with unstable angina pectoris and hospitalized on the same day for further evaluation and treatment.Per electronic data collection (edc), it was noted no action was taken to treat the event.Sixteen days later, the event was considered recovered/resolved and the subject was discharged on the same day on aspirin and ticagrelor.

Event Description

Synergy china registry: it was reported that unstable angina occurred.In (b)(6) 2020, the subject presented with unstable angina and was referred for cardiac catheterization.The index procedure was perfored on the same day.The target lesion #1 was located in the proximal left anterior descending artery (lad) extending up to mid lad with 99% stenosis and was 46 mm long and a reference vessel diameter of 3.00 mm.The target lesion #1 was treated with pre-dilatation and placement of a 2.50 mm x 24 mm overlapped with 3.00 mm x 28 mm synergy china stent system.Following this, the post dilatation was not performed.Post procedural residual stenosis was 0%.Two days later, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2021, the subject was diagnosed with unstable angina pectoris and hospitalized on the same day for further evaluation and treatment.It was noted no action was taken to treat the event.Sixteen days later, the event was considered recovered/resolved and the subject was discharged on the same day on aspirin and ticagrelor.It was further reported that in january 2021, medication was given to treat the event.

Manufacturer Narrative

(e1) initial reporter facility name: (b)(6).

Manufacturer Narrative

(e1) initial reporter facility name: (b)(6).

Event Description

(b)(6).It was reported that unstable angina occurred.In (b)(6) 2020, the subject presented with unstable angina and was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion #1 was located in the proximal left anterior descending artery (lad) extending up to mid lad with 99% stenosis and was 46 mm long and a reference vessel diameter of 3.00 mm.The target lesion #1 was treated with pre-dilatation and placement of a 2.50 mm x 24 mm overlapped with 3.00 mm x 28 mm synergy china stent system.Following this, the post dilatation was not performed.Post procedural residual stenosis was 0%.Two days later, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2021, the subject was diagnosed with unstable angina pectoris and hospitalized on the same day for further evaluation and treatment.It was noted no action was taken to treat the event.Sixteen days later, the event was considered recovered/resolved and the subject was discharged on the same day on aspirin and ticagrelor.It was further reported that in (b)(6) 2021, medication was given to treat the event.It was further reported that in (b)(6) 2021, surgery was performed to treat the event.

Event Description

Synergy china registry.It was reported that unstable angina occurred.In (b)(6) 2020, the subject presented with unstable angina and was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion was located in the proximal left anterior descending artery (lad) extending up to mid lad with 99% stenosis and was 46 mm long and a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 mm x 24 mm and 3.00 mm x 28 mm synergy stents in an overlapping manner following this, the post dilatation was not performed.Post procedural residual stenosis was 0%.Two days later, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2021, the subject was diagnosed with unstable angina pectoris and hospitalized on the same day for further evaluation and treatment.Medication was given to treat the event.Sixteen days later, the event was considered recovered and resolved.The subject was discharged on the same day on aspirin and ticagrelor.It was further reported that in (b)(6) 2021, surgery was performed and medication was given to treat the event.It was further reported that there was no surgery in (b)(6) 2021.Angiography without revascularization was performed.

Manufacturer Narrative

(e1) initial reporter facility name: (b)(6).

Manufacturer Narrative

(e1) initial reporter facility name: (b)(6) hospital.(h6) impact codes: surgical intervention has been added.(h6) patient code restenosis (e233701) has been added.

Event Description

Synergy china registry.It was reported that unstable angina occurred.In july 2020, the subject presented with unstable angina and was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion was located in the proximal left anterior descending artery (lad) extending up to mid lad with 99% stenosis and was 46 mm long and a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 mm x 24 mm and 3.00 mm x 28 mm synergy stents in an overlapping manner following this, the post dilatation was not performed.Post procedural residual stenosis was 0%.Two days later, the patient was discharged on aspirin and ticagrelor.In january 2021, the subject was diagnosed with unstable angina pectoris and hospitalized on the same day for further evaluation and treatment.Medication was given to treat the event.Sixteen days later, the event was considered recovered and resolved.The subject was discharged on the same day on aspirin and ticagrelor.It was further reported that in january 2021, surgery was performed, and medication was given to treat the event.It was further reported that there was no surgery in january 2021.Angiography without revascularization was performed.It was further reported that in january 2021, coronary artery bypass graft (cabg) was performed.It was further reported that in january 2021, medication was given to treat the event.Additionally, target vessel revascularization (tvr) as cabg was performed.Coronary angiography revealed an unknown % stenosis in the proximal lad to distal lad.The rationale for tvr was positive stress test or other objective evidence of cardiac ischemia.

Manufacturer Narrative

(e1) initial reporter facility name: (b)(6) university.(h6) impact codes: added surgical intervention.

Event Description

Synergy china registry.It was reported that unstable angina occurred.In (b)(6) 2020, the subject presented with unstable angina and was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion was located in the proximal left anterior descending artery (lad) extending up to mid lad with 99% stenosis and was 46 mm long and a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 mm x 24 mm and 3.00 mm x 28 mm synergy stents in an overlapping manner following this, the post dilatation was not performed.Post procedural residual stenosis was 0%.Two days later, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2021, the subject was diagnosed with unstable angina pectoris and hospitalized on the same day for further evaluation and treatment.Medication was given to treat the event.Sixteen days later, the event was considered recovered and resolved.The subject was discharged on the same day on aspirin and ticagrelor.It was further reported that in (b)(6) 2021, surgery was performed and medication was given to treat the event.It was further reported that there was no surgery in (b)(6) 2021.Angiography without revascularization was performed.It was further reported that in (b)(6) 2021, coronary artery bypass graft (cabg) was performed.

• Brand Name: SYNERGY
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 12418968
• MDR Text Key: 269780087
• Report Number: 2134265-2021-10583
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/22/2022

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: 01/27/2022
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0025159742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 11/08/2021; 05/19/2022; 08/04/2022; 10/13/2022; 11/07/2022
• Supplement Dates FDA Received: 11/19/2021; 06/07/2022; 08/08/2022; 10/28/2022; 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female