MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC SYNERGY MR; BOSTON SCIENTIFIC SYNERGY MR STENT

Catalog Number 39260-2835

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Chest Pain (1776); Occlusion (1984); Thrombus (2101)

Event Date 05/17/2018

Event Type  Injury  

Event Description

On (b)(6) 2017 patient admitted through er with stemi, taken emergently to ccl where films reveal totally occluded mid rca consistent with large amount of thrombus.Overlapping inflations performed with 2.5x15 emerge providing sluggish flow.Thrombectomy performed and brisk flow returned with minimal residual defect.The 3.5x28 synergy deployed with good results.Procedure medications include asa 325 mg, heparin, and brilinta.Patient did well and was discharged (b)(6) 2017 on medications including asa 81 mg qd, and brilinta 90mg bid.On (b)(6) 2018 1000 patient has chest pain, calls ems, and takes asa and brilinta before their arrival.To er with stemi.Ccl films reveal total thrombotic occlusion of previously placed stent.H and p notes that patient had done well post op, but at office visit (b)(6) 2018 states that he has stopped asa on his own and is taking brilinta only.Unclear from chart whether patient resumed asa then, only that he took asa and brilinta that morning when he called ems.Mid rca treated with thrombectomy, and 3.5x20 nc emerge with restoration of timi iii flow.Procedure medications include heparin, and prasugrel in addition to the patient's asa and brilinta at home.Patient did well and discharged (b)(6) 2018 on medications including asa 325mg qd and prasugrel 10 mg qd.

• Brand Name: BOSTON SCIENTIFIC SYNERGY MR
• Type of Device: BOSTON SCIENTIFIC SYNERGY MR STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 7564928
• MDR Text Key: 110068049
• Report Number: MW5077592
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2018
• Device Catalogue Number: 39260-2835
• Device Lot Number: 20618609
• 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: 87 YR
• Patient Weight: 86