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

Model Number 10623

Device Problem Obstruction of Flow (2423)

Patient Problems Atherosclerosis (1728); Reocclusion (1985); Thrombosis (2100); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 10/28/2020

Event Type  Injury  

Event Description

(b)(6) study.It was reported that in-stent restenosis occurred.In (b)(6) 2019, the subject was referred for cardiac catherization and on the same day index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) extended to mid lad with 90% stenosis and was 35 mm long, with a reference vessel diameter of 3 mm.The target lesion was treated with pre-dilatation and placement of a 3.00x38mm synergy stent system the residual stenosis was 0%.Post dilation was not performed.The following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The following day, the subject was referred for coronary angiography which revealed 70% proximal to mid lad stenosis which was treated with drug balloon dilatation percutaneous coronary intervention - target vessel revascularization.Post intervention, residual stenosis was 0%.The following day, the subject was discharged on aspirin and clopidogrel.

Event Description

Synergy china registry clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2019, the subject was referred for cardiac catherization and on the same day index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) extended to mid lad with 90% stenosis and was 35 mm long, with a reference vessel diameter of 3 mm.The target lesion was treated with pre-dilatation and placement of a 3.00x38mm synergy stent system the residual stenosis was 0%.Post dilation was not performed.The following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The following day, the subject was referred for coronary angiography which revealed 70% proximal to mid lad stenosis which was treated with drug balloon dilatation percutaneous coronary intervention - target vessel revascularization.Post intervention, residual stenosis was 0%.The following day, the subject was discharged on aspirin and clopidogrel.It was further reported that the event was classified as stent thrombosis.

Event Description

Synergy china registry clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2019, the subject was referred for cardiac catherization and on the same day index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) extended to mid lad with 90% stenosis and was 35 mm long, with a reference vessel diameter of 3 mm.The target lesion was treated with pre-dilatation and placement of a 3.00x38mm synergy stent system the residual stenosis was 0%.Post dilation was not performed.The following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The following day, the subject was referred for coronary angiography which revealed 70% proximal to mid lad stenosis which was treated with drug balloon dilatation percutaneous coronary intervention - target vessel revascularization.Post intervention, residual stenosis was 0%.The following day, the subject was discharged on aspirin and clopidogrel.It was further reported that the event was classified as stent thrombosis.It was further reported that stent thrombosis did not occur and the event should have remained as the in-stent restenosis originally reported.The event was considered to be recovering/resolving.

• 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: 10932034
• MDR Text Key: 219129009
• Report Number: 2134265-2020-16765
• 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
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2020
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0023575184
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR