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

Model Number 10622

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/05/2020

Event Type  Injury  

Event Description

(b)(6) registry.It was reported that the subject experienced symptoms related coronary atherosclerotic heart disease and was hospitalized.In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization, the index procedure was performed on the same day.The target lesion was located in the mid left circumflex (lcx) extending up to distal lcx with 100% stenosis and was 59 mm long, with a reference vessel diameter of 2.75 mm.The target lesion was treated with pre-dilatation and with placement of a 2.50 mm x 32mm and a 2.75mm x 32 mm synergy drug-eluting stent system.Following post-dilatation, the residual stenosis was 0%.The following day the patient was discharged.In (b)(6) 2020, unknown number of days post index procedure, the subject presented with symptoms related to coronary atherosclerotic heart disease and was hospitalized for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease and balloon dilation was performed to treat the event.The subject was discharged and the event was considered to be recovering/resolving.The lesion location of the balloon dilation treatment is unknown and the physician assessed it as unlikely related to the study device.In (b)(6) 2020, 335 days post index procedure, the subject presented with [unknown] symptoms related to coronary atherosclerotic heart disease and on the same day was hospitalized for further evaluation and treatment.The patient was diagnosed with coronary atherosclerotic heart disease and angiography without revascularization was performed during the event.No other action was taken, however, the physician assessment that the event was related to the study device was reported as possible.Two days later, the subject was discharged and 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
• 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: 10683346
• MDR Text Key: 211459647
• Report Number: 2134265-2020-13882
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2019
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0022194140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2018
• 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; Other
• Patient Age: 58 YR