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 Problem Complaint, Ill-Defined (2331)

Event Date 09/10/2020

Event Type  Injury  

Event Description

(b)(6).It was reported that the subject experienced symptoms of coronary atherosclerotic heart disease.In (b)(6) 2019, the index procedure was performed.The target lesion was located in the proximal right coronary artery (rca) extended to mid rca with 100% stenosis and was 30 mm long, with a reference vessel diameter of 3.4 mm.The target lesion was treated with pre-dilatation and placement of a 3.50 x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Nine days later, the subject was discharged on aspirin and other antiplatelet medications.In (b)(6) 2020, 322 days post index procedure, the subject presented with symptoms of 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 and event was treated medically.Two days later, the event was considered recovering/resolving and the subject was discharged on aspirin and other antiplatelet medications.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10779589
• MDR Text Key: 214380586
• Report Number: 2134265-2020-15048
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2020
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0023583312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2019
• 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
• Patient Age: 52 YR