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

Catalog Number H7493941838300

Device Problems Complete Blockage (1094); Coagulation in Device or Device Ingredient (1096)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Sepsis (2067); Thrombosis/Thrombus (4440)

Event Date 05/07/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, patient was transferred to our hospital for nonstemi.To cath lab where films reveal a total occlusion of mid lad, which appeared to be a chronic total occlusion but patient reports chest pain for only 5 days.The lesion was pre dilated with a 2.5x20 emerge otw, and a 3x30 emerge rx, multiple inflations.A 3x38 synergy xd was deployed and it's balloon re-inflated to post dilate.A 3x20 synergy xd deployed more proximal and it's balloon re-inflated to post dilate.Patient did well, and dc'd (b)(6) 2021 on asa 325 mg qd and plavix 75 mg qd.Patient admitted to hospital for uti sepsis (b)(6) 2021, no complaints of chest pain during this admission.On (b)(6) 2021, patient presents to outlying er with chest pain of one hour duration.Diagnosed with stemi and transferred to our cath lab for emergent pci.Previously placed stents with 100% thrombotic occlusion.Patient stated that she had faithfully taken asa and plavix with no missed doses.Thrombectomy performed, and a 3.5x30 nc emerge rx used.Final results with 0% residual stenosis and timi iii flow.Patient did well, and was dc'd (b)(6) 2021 on asa 325 mg qd and brilinta 90 mg bid.Fda safety report id # (b)(4).

• Brand Name: SYNERGY XD
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12353612
• MDR Text Key: 267832344
• Report Number: MW5103380
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/18/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2022
• Device Catalogue Number: H7493941838300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 100