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

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); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Restenosis (4576)

Event Date 03/23/2021

Event Type Injury

Event Description

(b)(6) registry.It was reported that chronic heart failure and stent thrombosis occurred.In (b)(6) 2020, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was located in the mid left anterior descending artery(lad), extended to 2nd diagonal with 95% stenosis and was 60mm long with a reference vessel diameter of 3.5mm.The target lesion was treated with pre-dilatation and placement of a 2.50mm x 32mm synergy drug-eluting stent and overlapped with 3.50mm x 32mm synergy drug-eluting stent.Post dilation was performed with 0% residual stenosis.Four days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2021, the subject was diagnosed with chronic heart failure and was hospitalized on the same day for further evaluation and treatment.No other action was taken to treat the event.Per electronic data collection (edc), it was noted the event would qualify for clinical events committee(cec) of stent thrombosis.At the time of reporting, the event was considered as not recovered/not resolved.Seventeen days later, the subject was discharged.

Manufacturer Narrative

Correction: (h6) patient codes: thrombosis/thrombus (e0514) initially reported and has now been removed.

Event Description

Synergy china registry: it was reported that chronic heart failure and stent thrombosis occurred.In (b)(6) 2020, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion was located in the mid left anterior descending artery(lad), extended to 2nd diagonal with 95% stenosis and was 60mm long with a reference vessel diameter of 3.5mm.The target lesion was treated with pre-dilatation and placement of a 2.50mm x 32mm synergy drug-eluting stent and overlapped with 3.50mm x 32mm synergy drug-eluting stent.Post dilation was performed with 0% residual stenosis.Four days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2021, the subject was diagnosed with chronic heart failure and was hospitalized on the same day for further evaluation and treatment.No other action was taken to treat the event.Per electronic data collection (edc), it was noted the event would qualify for clinical events committee(cec) of stent thrombosis.At the time of reporting, the event was considered as not recovered/not resolved.Seventeen days later, the subject was discharged.It was further reported that the event did not qualify for stent thrombosis per clinical events committee (cec).Therefore, the diagnosis of stent thrombosis was removed.

Manufacturer Narrative

Correction: (h6) patient code: restenosis (e233701) has been added.(h6) patient code: heart failure/congestive heart failure (e0311) initially removed, however, added back due to event qualification.

Event Description

Same case as (b)(4).Synergy china registry it was reported that chronic heart failure occurred.In (b)(6) 2020, subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the mid left anterior descending artery (lad) extended to 2nd diagram with 95% stenosis and was 60 mm long and a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 mm x 32 mm and overlapped with 3.50 mm x 32 mm synergy drug-eluting stent.Following this post dilation was performed with 0% residual stenosis.Four days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2021, post index procedure, subject was diagnosed with chronic heart failure and was hospitalized on the same day for further evaluation and treatment.No other action was taken to treat the event.The event would qualify for cec of stent thrombosis.At the time of reporting, the event was considered as not recovered and not resolved.Two weeks and three days later, the subject was discharged.It was further reported that the event did not qualify for stent thrombosis per clinical events committee (cec).Therefore, the diagnosis of stent thrombosis was removed.It was further reported that the event did not qualify for chronic heart failure.The subject was diagnosed with stable angina in (b)(6) 2021.The subject was hospitalized on the same day for further evaluation and treatment.Medication was provided to treat the stable angina.At the time of reporting, the event was considered as not recovered/not resolved.(b)(6) 2021, the subject was discharged.It was previously reported that the event did not qualify for chronic heart failure (chf); however, the chf occurred in (b)(6) 2021 and does still qualify.The subject was diagnosed with stable angina, hospitalized and treated with medication in (b)(6) 2021.The relationship to study device is probable as correlation is observed due to restenosis.

Event Description

Same case as pr id# (b)(4).Synergy china registry.It was reported that chronic heart failure occurred.In october 2020, subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the mid left anterior descending artery (lad) extended to 2nd diagram with 95% stenosis and was 60 mm long and a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 mm x 32 mm and overlapped with 3.50 mm x 32 mm synergy drug-eluting stent.Following this post dilation was performed with 0% residual stenosis.Four days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2021, post index procedure, subject was diagnosed with chronic heart failure and was hospitalized on the same day for further evaluation and treatment.No other action was taken to treat the event.The event would qualify for cec of stent thrombosis.At the time of reporting, the event was considered as not recovered and not resolved.Two weeks and three days later, the subject was discharged.It was further reported that the event did not qualify for stent thrombosis per clinical events committee (cec).Therefore, the diagnosis of stent thrombosis was removed.It was further reported that the event did not qualify for chronic heart failure.The subject was diagnosed with stable angina in (b)(6) 2021.The subject was hospitalized on the same day for further evaluation and treatment.Medication was provided to treat the stable angina.At the time of reporting, the event was considered as not recovered/not resolved.July 2021, the subject was discharged.

Manufacturer Narrative

Correction: (b2) outcomes attrib to adverse event: required intervention to prevent permanent impairment/damage added.(h6) patient codes: heart failure/congestive heart failure (e0611) initially reported and has now been updated.(h6) impact codes: medication required (f2303) added.

Event Description

Same case as pr id# (b)(6).Synergy china registry.It was reported that chronic heart failure occurred.In (b)(6) 2020, subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the mid left anterior descending artery (lad) extended to 2nd diagram with 95% stenosis and was 60 mm long and a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 mm x 32 mm and overlapped with 3.50 mm x 32 mm synergy drug-eluting stent.Following this post dilation was performed with 0% residual stenosis.Four days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2021, post index procedure, subject was diagnosed with chronic heart failure and was hospitalized on the same day for further evaluation and treatment.No other action was taken to treat the event.The event would qualify for cec of stent thrombosis.At the time of reporting, the event was considered as not recovered and not resolved.Two weeks and three days later, the subject was discharged.It was further reported that the event did not qualify for stent thrombosis per clinical events committee (cec).Therefore, the diagnosis of stent thrombosis was removed.It was further reported that the event did not qualify for chronic heart failure.The subject was diagnosed with stable angina in (b)(6) 2021.The subject was hospitalized on the same day for further evaluation and treatment.Medication was provided to treat the stable angina.At the time of reporting, the event was considered as not recovered/not resolved.(b)(6) 2021, the subject was discharged.It was previously reported that the event did not qualify for chronic heart failure; however, the chronic heart failure occurred in (b)(6) 2021 and does still qualify.Medication was given to treat the event.In (b)(6) 2021, the subject was diagnosed with stable angina, hospitalized and treated with medication.The relationship of angina to study device is probable as correlation is observed due to restenosis.At the time of reporting, both events were considered not recovered/not resolved.It was further reported that the target lesion 1 was located in the left main coronary artery (lmca) extending up to the mid lad artery.

Event Description

Same case as pr id# (b)(4).Synergy china registry: it was reported that chronic heart failure occurred.In october 2020, subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the mid left anterior descending artery (lad) extended to 2nd diagram with 95% stenosis and was 60 mm long and a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 mm x 32 mm and overlapped with 3.50 mm x 32 mm synergy drug-eluting stent.Following this post dilation was performed with 0% residual stenosis.Four days later, the subject was discharged on aspirin and clopidogrel.In march 2021, post index procedure, subject was diagnosed with chronic heart failure and was hospitalized on the same day for further evaluation and treatment.No other action was taken to treat the event.The event would qualify for cec of stent thrombosis.At the time of reporting, the event was considered as not recovered and not resolved.Two weeks and three days later, the subject was discharged.It was further reported that the event did not qualify for stent thrombosis per clinical events committee (cec).Therefore, the diagnosis of stent thrombosis was removed.It was further reported that the event did not qualify for chronic heart failure.The subject was diagnosed with stable angina in june 2021.The subject was hospitalized on the same day for further evaluation and treatment.Medication was provided to treat the stable angina.At the time of reporting, the event was considered as not recovered/not resolved.July 2021, the subject was discharged.It was previously reported that the event did not qualify for chronic heart failure; however, the chronic heart failure occurred in march 2021 and does still qualify.Medication was given to treat the event.In june 2021, the subject was diagnosed with stable angina, hospitalized and treated with medication.The relationship of angina to study device is probable as correlation is observed due to restenosis.At the time of reporting, both events were considered not recovered/not resolved.It was further reported that the target lesion 1 was located in the left main coronary artery (lmca) extending up to the mid lad artery.It was further reported that in april 2021, the event of chronic heart failure was considered to be recovering/resolving.

Manufacturer Narrative

E1- initial reporter address 1: (b)(6).Updated: e1- initial reporter's address.B5- describe event or problem.

Event Description

Same case as pr id# (b)(4).Synergy china registry.It was reported that chronic heart failure occurred.In (b)(6) 2020, subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the mid left anterior descending artery (lad) extended to 2nd diagram with 95% stenosis and was 60 mm long and a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 mm x 32 mm and overlapped with 3.50 mm x 32 mm synergy drug-eluting stent.Following this post dilation was performed with 0% residual stenosis.Four days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2021, post index procedure, subject was diagnosed with chronic heart failure and was hospitalized on the same day for further evaluation and treatment.No other action was taken to treat the event.The event would qualify for cec of stent thrombosis.At the time of reporting, the event was considered as not recovered and not resolved.Two weeks and three days later, the subject was discharged.It was further reported that the event did not qualify for stent thrombosis per clinical events committee (cec).Therefore, the diagnosis of stent thrombosis was removed.It was further reported that the event did not qualify for chronic heart failure.The subject was diagnosed with stable angina in (b)(6) 2021.The subject was hospitalized on the same day for further evaluation and treatment.Medication was provided to treat the stable angina.At the time of reporting, the event was considered as not recovered/not resolved.(b)(6) 2021, the subject was discharged.It was previously reported that the event did not qualify for chronic heart failure; however, the chronic heart failure occurred in (b)(6) 2021 and does still qualify.Medication was given to treat the event.In (b)(6) 2021, the subject was diagnosed with stable angina, hospitalized and treated with medication.The relationship of angina to study device is probable as correlation is observed due to restenosis.At the time of reporting, both events were considered not recovered/not resolved.It was further reported that the target lesion 1 was located in the left main coronary artery (lmca) extending up to the mid lad artery.It was further reported that in (b)(6) 2021, the event of chronic heart failure was considered to be recovering/resolving.It was further reported that in (b)(6) 2021, the patient was identified as having restenosis and was referred for coronary angiography.There was 90% stenosis noted in lmca extending up to proximal lad which had previously placed study device and was treated with percutaneous coronary intervention (pci) target vessel revascularization (tvr).Post intervention, residual stenosis was 9%.The rationale for intervention was angina and symptoms of ischemia.At the time of reporting, the event was considered to be recovering/resolving.

Manufacturer Narrative

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

Event Description

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Brand Name

SYNERGY

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

Manufacturer Contact

rachel shields

4100 hamline ave n

arden hills, MN 55112

6512422111

MDR Report Key

11810247

MDR Text Key

250223737

Report Number

2134265-2021-06174

Device Sequence Number

Product Code

NIQ

Combination Product (y/n)

Reporter Country Code

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Other,Foreign,Study,Health Professional,Company Representative

Reporter Occupation

Physician

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

05/11/2021

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

12/21/2020

Device Model Number

10622

Device Catalogue Number

10622

Device Lot Number

0024020343

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Yes

Date Manufacturer Received

09/27/2023

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

06/25/2019

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Hospitalization; Required Intervention; Other;

Patient Age

68 YR

Patient Sex

Male

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

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