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

Model Number 10620

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

Patient Problem Angina (1710)

Event Date 12/05/2020

Event Type  Injury  

Event Description

(b)(6) registry.It was reported that unstable angina occurred.In (b)(6) 2019, the subject was referred to cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the distal left circumflex (lcx) artery with 90% stenosis and was 24 mm long and a reference vessel diameter of 2.25 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 28 mm synergy study stent.Following this post dilation was performed with 0% residual stenosis.The target lesion 2 was located in the mid left anterior descending (lad) artery with 90% stenosis and was 38 mm long and a reference vessel diameter of 2.50 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 38 mm overlapped with 2.75 mm x 24 mm synergy study stents.Following this post dilation was performed with 0% residual stenosis.Three days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment.Three days later, coronary angiography revealed 50% stenosis in distal lcx and it was treated with percutaneous coronary intervention (pci) - target-vessel revascularization (tvr).Post intervention, residual stenosis was 0%.The rationale for tvr was angina.At the time of reporting the event was not recovered and not resolved.Six days after hospitalization, the subject was discharged.

Event Description

Synergy china registry.It was reported that unstable angina and restenosis occurred.In (b)(6) 2019, the subject was referred to cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the distal left circumflex (lcx) artery with 90% stenosis and was 24 mm long and a reference vessel diameter of 2.25 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 28 mm synergy study stent.Following this post dilation was performed with 0% residual stenosis.The target lesion 2 was located in the mid left anterior descending (lad) artery with 90% stenosis and was 38 mm long and a reference vessel diameter of 2.50 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 38 mm overlapped with 2.75 mm x 24 mm synergy study stents.Following this post dilation was performed with 0% residual stenosis.Three days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment.Three days later, coronary angiography revealed 50% stenosis in distal lcx and it was treated with percutaneous coronary intervention (pci) - target-vessel revascularization (tvr).Post intervention, residual stenosis was 0%.The rationale for tvr was angina.At the time of reporting the event was not recovered and not resolved.Six days after hospitalization, the subject was discharged.It was further reported that the target lesion 2 was 57mm long instead of 38mm long as previously reported.In (b)(6) 2020, the subject was discharged on aspirin and clopidogrel.

Event Description

Synergy china registry it was reported that unstable angina and restenosis occurred.In november 2019, the subject was referred to cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the distal left circumflex (lcx) artery with 90% stenosis and was 24 mm long and a reference vessel diameter of 2.25 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 28 mm synergy study stent.Following this post dilation was performed with 0% residual stenosis.The target lesion 2 was located in the mid left anterior descending (lad) artery with 90% stenosis and was 38 mm long and a reference vessel diameter of 2.50 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 38 mm overlapped with 2.75 mm x 24 mm synergy study stents.Following this post dilation was performed with 0% residual stenosis.Three days later, the subject was discharged on aspirin and clopidogrel.In december 2020, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment.Three days later, coronary angiography revealed 50% stenosis in distal lcx and it was treated with percutaneous coronary intervention (pci) - target-vessel revascularization (tvr).Post intervention, residual stenosis was 0%.The rationale for tvr was angina.At the time of reporting the event was not recovered and not resolved.Six days after hospitalization, the subject was discharged.It was further reported that the target lesion 2 was 57mm long instead of 38mm long as previously reported.In december 2020, the subject was discharged on aspirin and clopidogrel.It was further reported that the 2.25 mm x 28 mm synergy study stent had in-stent restenosis noted in the distal lcx.The rationale for tvr was angina and angiographic finding without symptoms or objective signs of ischemia.

Manufacturer Narrative

A3 sex updated from male to female.B5 describe event or problem has been updated.B7 other relevant history has been updated.

Event Description

Synergy china registry.It was reported that unstable angina and restenosis occurred.In (b)(6) 2019, the subject was referred to cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the distal left circumflex (lcx) artery with 90% stenosis and was 24 mm long and a reference vessel diameter of 2.25 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 28 mm synergy study stent.Following this post dilation was performed with 0% residual stenosis.The target lesion 2 was located in the mid left anterior descending (lad) artery with 90% stenosis and was 38 mm long and a reference vessel diameter of 2.50 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 38 mm overlapped with 2.75 mm x 24 mm synergy study stents.Following this post dilation was performed with 0% residual stenosis.Three days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment.Three days later, coronary angiography revealed 50% stenosis in distal lcx and it was treated with percutaneous coronary intervention (pci) - target-vessel revascularization (tvr).Post intervention, residual stenosis was 0%.The rationale for tvr was angina.At the time of reporting the event was not recovered and not resolved.Six days after hospitalization, the subject was discharged.It was further reported that the target lesion 2 was 57mm long instead of 38mm long as previously reported.In (b)(6) 2020, the subject was discharged on aspirin and clopidogrel.It was further reported that the 2.25 mm x 28 mm synergy study stent had in-stent restenosis noted in the distal lcx.The rationale for tvr was angina and angiographic finding without symptoms or objective signs of ischemia.It was further reported that in (b)(6) 2020, the event was considered to be recovering and resolving.

Manufacturer Narrative

A3 sex - corrected from female to male.

Event Description

Synergy china registry it was reported that unstable angina and restenosis occurred.In (b)(6) 2019, the subject was referred to cardiac catheterization and the index procedure was performed on the same day.The target lesion 1 was located in the distal left circumflex (lcx) artery with 90% stenosis and was 24 mm long and a reference vessel diameter of 2.25 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 28 mm synergy study stent.Following this post dilation was performed with 0% residual stenosis.The target lesion 2 was located in the mid left anterior descending (lad) artery with 90% stenosis and was 38 mm long and a reference vessel diameter of 2.50 mm.The target lesion was treated with pre-dilatation and placement of a 2.25 mm x 38 mm overlapped with 2.75 mm x 24 mm synergy study stents.Following this post dilation was performed with 0% residual stenosis.Three days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject was diagnosed with unstable angina and was hospitalized on the same day for further evaluation and treatment.Three days later, coronary angiography revealed 50% stenosis in distal lcx and it was treated with percutaneous coronary intervention (pci) - target-vessel revascularization (tvr).Post intervention, residual stenosis was 0%.The rationale for tvr was angina.At the time of reporting the event was not recovered and not resolved.Six days after hospitalization, the subject was discharged.It was further reported that the target lesion 2 was 57mm long instead of 38mm long as previously reported.In (b)(6) 2020, the subject was discharged on aspirin and clopidogrel.It was further reported that the 2.25 mm x 28 mm synergy study stent had in-stent restenosis noted in the distal lcx.The rationale for tvr was angina and angiographic finding without symptoms or objective signs of ischemia.It was further reported that in (b)(6) 2020, the event was considered to be recovering and resolving.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 12617727
• MDR Text Key: 275985234
• Report Number: 2134265-2021-12554
• 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: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2020
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0023654866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2019
• 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; Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Male