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

Lot Number 0029942056

Device Problem Obstruction of Flow (2423)

Patient Problems Dyspnea (1816); Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Respiratory Insufficiency (4462); Renal Impairment (4499)

Event Date 05/09/2023

Event Type  Injury  

Event Description

It was reported via user medwatch mw5120195 that multiple patient issues occurred.On (b)(6) 2023, the patient presented to the emergency department with chest pressure and increasing shortness of breath and was transferred to another facility for cardiac catheterization.Films revealed multivessel disease and the decision was made to proceed with percutaneous intervention of the left main (lm)/proximal left anterior descending artery (lad) and the left dominant proximal circumflex (cx) artery.The 90% stenosed cx was treated with a 3.50 non-boston scientific (non-bsc) non-complaint (nc) balloon, and placement of a 4.00 x 38 synergy xd stent.The stent was post-dilated with a 4.50 x 12 non-bsc nc balloon and final films revealed good result with timi iii flow.The patient continued to do well and was discharged on aspirin and plavix.The patient reported being compliant with their medications.On (b)(6) 2023, the patient returned to the emergency department with increasing shortness of breath and no chest discomfort.Over the next week the patient was treated for respiratory distress, acute on chronic congestive heart failure, acute kidney injury, and non-st elevation myocardial infarction.The patient's respiratory and renal function stabilized, and they were transferred to the same facility as previously for another catheterization.Repeat catheterization films revealed subacute thrombosis of the previously placed stent in the proximal cx.The thrombosis was treated with 3.00 x 15 and 4.50 x 15 non-bsc nc balloons and with multiple passes with a non-bsc aspiration catheter.Final films revealed timi iii flow.The patient continued to do well and was discharged on medications including aspiring and plavix.

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17750255
• MDR Text Key: 323471023
• Report Number: 2124215-2023-49483
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981176
• UDI-Public: 08714729981176
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0029942056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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; Hospitalization