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

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/30/2023

Event Type  Injury  

Event Description

It was reported that acute stent thrombosis occurred.A 3.50 x 20mm synergy drug-eluting stent was implanted on an unspecified date.Catheterization was performed which revealed acute stent thrombosis.It was noted that the patient did not get dual antiplatelet therapy, and was only on aspirin and another medication so, it was thought that it was an anti-coagulation issue.There were no further patient complications nor injuries reported.

Event Description

It was reported that acute stent thrombosis occurred.A 3.50 x 20mm synergy drug-eluting stent was implanted on an unspecified date.Catheterization was performed which revealed acute stent thrombosis.It was noted that the patient did not get dual antiplatelet therapy, and was only on aspirin and another medication so, it was thought that it was an anti-coagulation issue.There were no further patient complications nor injuries reported.It was further reported that angiogram led to the discovery of stent thrombosis.The 95% stenosed target lesion was located in the proximal right coronary artery.The physician tried to perform percutaneous coronary intervention (pci) to resolve the event but was unsuccessful crossing the previously placed stent.The patient was going to be transferred to another hospital to perform intervention.The patient had no symptoms related to the issue.

• Brand Name: SYNERGY XD
• 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: 16404598
• MDR Text Key: 309860518
• Report Number: 2124215-2023-05913
• Device Sequence Number: 1
• Product Code: NIQ
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• 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