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

Model Number 10623

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

Patient Problems Death (1802); Heart Failure (2206)

Event Date 12/01/2020

Event Type  Death  

Event Description

Synergy (b)(6) registry.It was reported that the patient died.In (b)(6) 2019, the subject was referred for cardiac catherization.The index procedure was performed and the subject was enrolled on the same day.The target lesion was located in the distal left circumflex artery (lcx) with 85% stenosis and was 35mm long with a reference vessel diameter of 2.75mm.The lesion treated with direct deployment of a 2.75mm x 38mm synergy stent system.Following post-dilatation the residual stenosis was 5%.Two weeks and four days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2020, the subject experienced cardiac insufficiency and on an unknown date the subject expired with an unknown cause of death.No action was taken to treat the event and it is unknown if an autopsy was performed.No other additional information is available at this time of report.

Manufacturer Narrative

E1 initial reporter address 1: (b)(6).Correction: b3 event date: (b)(6) 2020, initially reported.And correct event date should have been (b)(6) 2020.No event date was provided.Therefore, the first date of the month of the aware date was used.

Event Description

Synergy china registry: it was reported, that the patient died.In (b)(6) 2019, the subject was referred for cardiac catherization.The index procedure was performed, and the subject was enrolled on the same day.The target lesion was located in the distal left circumflex artery (lcx) with 85% stenosis, and was 35mm long with a reference vessel diameter of 2.75mm.The lesion treated with direct deployment of a 2.75mm x 38mm synergy stent system.Following post-dilatation, the residual stenosis was 5%.Two weeks and four days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2020, the subject experienced cardiac insufficiency.And on an unknown date, the subject expired with an unknown cause of death.No action was taken to treat the event.And it is unknown, if an autopsy was performed.No other additional information is available at this time of report.

Manufacturer Narrative

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

Event Description

Synergy china registry.It was reported that the patient died.On (b)(6) 2019, the subject was referred for cardiac catherization.The index procedure was performed and the subject was enrolled on the same day.The target lesion was located in the distal left circumflex artery (lcx) with 85% stenosis and was 35mm long with a reference vessel diameter of 2.75mm.The lesion treated with direct deployment of a 2.75mm x 38mm synergy stent system.Following post-dilatation the residual stenosis was 5%.Two weeks and four days later, the subject was discharged on aspirin and ticagrelor.On (b)(6) 2020, the subject experienced cardiac insufficiency and on an unknown date the subject expired with an unknown cause of death.No action was taken to treat the event and it is unknown if an autopsy was performed.No other additional information is available at this time of report.It was further reported that, per edc, the stent was deployed without any device deficiency.

• 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: 11059447
• MDR Text Key: 223353598
• Report Number: 2134265-2020-18369
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2020
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0023953162
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR