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

Model Number 10618

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

Patient Problems Ischemia (1942); Restenosis (4576); Insufficient Information (4580)

Event Date 07/06/2020

Event Type  Injury  

Event Description

Synergy china registry.It was reported that acute coronary syndrome and restenosis occurred.In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization.On the same day, index procedure was performed.The target lesion 1 was located in the proximal left anterior descending artery (lad) extended up to mid lad with 99% stenosis and was 27 mm long with a reference vessel diameter of 2.25 mm.The target lesion 1 was treated with pre-dilatation and placement of a 2.25 mm x 16 mm and 2.75 x 16 mm synergy stent systems.Following post-dilatation, the residual stenosis was noted to be 0%.The target lesion 2 was located in the proximal right coronary artery (rca) extended up to mid rca with 95% stenosis and was 47 mm long with a reference vessel diameter of 2.75 mm.The target lesion 2 was treated with pre-dilatation and placement of a 3.00 mm x 16 mm and 2.75 mm x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Four days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject was diagnosed with acute coronary syndrome and was hospitalized for further evaluated and treatment.Seven days later, the subject was referred for coronary angiography which revealed 80% stenosis noted in proximal lad extending up to middle lad was treated with percutaneous coronary intervention.Post intervention, the residual stenosis was 0%.Fifteen days after, the subject was discharged on aspirin and clopidogrel.

Manufacturer Narrative

H6: updated to ischemia.

Event Description

Synergy china registry it was reported that restenosis and acute coronary syndrome occurred.In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization.The target lesion 1 was located in the proximal left anterior descending artery (lad) extended up to mid lad with 99% stenosis and was 27 mm long with a reference vessel diameter of 2.25 mm.The target lesion 1 was treated with pre-dilatation and placement of a 2.25 mm x 16 mm and 2.75 x 16 mm synergy stent systems.Following post-dilatation, the residual stenosis was noted to be 0%.The target lesion 2 was located in the proximal right coronary artery (rca) extended up to mid rca with 95% stenosis and was 47 mm long with a reference vessel diameter of 2.75 mm.The target lesion 2 was treated with pre-dilatation and placement of a 3.00 mm x 16 mm and 2.75 mm x 38 mm synergy stent systems.Following post-dilatation, the residual stenosis was noted to be 0%.Four days later, the subject was discharged on aspirin and clopidogrel.In july 2020, the subject was diagnosed with acute coronary syndrome and was hospitalized for further evaluated and treatment.Seven days later, the subject was referred for coronary angiography which revealed 80% stenosis in proximal lad extending up to middle lad and was treated with percutaneous coronary intervention (target vessel revascularization).Post intervention, the residual stenosis was 0%.Fifteen days after, the subject was discharged on aspirin and clopidogrel.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18887283
• MDR Text Key: 337457562
• Report Number: 2124215-2024-13458
• 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: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2020
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0023593540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2019
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male