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

Model Number 9534

Device Problem Obstruction of Flow (2423)

Patient Problem Restenosis (4576)

Event Date 04/03/2020

Event Type  Injury  

Event Description

Agent ide.It was reported that in-stent restenosis occurred.In (b)(6) 2016, a complex chronic total occlusion of the right coronary artery (rca) was treated with 3.0 mm x 38 mm, 2.5 mm x 24 mm, and 3.5 mm x 38 mm synergy drug eluting stents.In (b)(6) 2020, 80% in-stent restenosis was noted at the proximal rca and was treated with a 4.0 mm x 16 mm synergy drug eluting stent.The proximal left anterior descending artery (lad) was noted to be100% stenosis and was treated with 2.5 mm x 20 mm and 3.0 mm x 16 mm synergy drug eluting stents.

• 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: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15680705
• MDR Text Key: 302491783
• Report Number: 2124215-2022-42996
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9534
• Device Catalogue Number: 9534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 82 YR
• Patient Sex: Male
• Patient Race: White