MAUDE Adverse Event Report: BOSTON SCIENTIFIC SYNERGY MR 2.5 X 20; CORONARY DRUG-ELUTING STENT

Catalog Number 39260-2025

Device Problem Occlusion Within Device (1423)

Patient Problem Pseudoaneurysm (2605)

Event Date 06/16/2017

Event Type  Injury  

Event Description

On (b)(6) 2017 0325 patient arrived to our er with stemi.Taken emergently to ccl, where films reveal 90 percent lesion r pda.Pre dilated with 2.5 x 15 emerge mr 2.5 x 20 and 2.5 x 8 synergy mr deployed overlapping with good results.Timi iii flow and 0 percent residual stenosis.Patient discharged (b)(6) 2017 with instructions for asa 81 mg, plavix 75 mg, and coumadin 5 mg, but do not continue xarelto.Patient returned to er (b)(6) 2017 with rt femoral pseudoaneurysm which was treated medically.Pt discharged (b)(6) 2017 instructed to continue only asa and plavix at this time due to groin complication.Patient got confused at home regarding medications and took none.Returned to er (b)(6) 2017 1130 with stemi.Taken emergently to ccl where films reveal 100% thrombotic occlusion of previously placed stents in r pda.Treated with 2.5 x 15 emerge mr overlapping inflations, and timi iii flow is restored, 0 percent residual stenosis.Patient discharged (b)(6) 2017 with instructions of asa 81 mg and brilinta 90 mg bid.

• Brand Name: SYNERGY MR 2.5 X 20
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 6676478
• MDR Text Key: 78908087
• Report Number: MW5070686
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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: 06/27/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2018
• Device Catalogue Number: 39260-2025
• Device Lot Number: 20341814
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 93