MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Congestive Heart Failure (1783); Death (1802)

Event Date 01/02/2018

Event Type  Death  

Event Description

Evolve ii.It was reported there was a patient death.In (b)(6) 2013 the subject presented with stable angina.Prior to procedure, the subject was found to have abnormal stress test or imaging stress test indicative of ischemia and the subject was referred for cardiac catheterization.Target lesion #1 was located in the ramus with 90% stenosis and was 22 mm long with a reference vessel diameter of 2.5 mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.50 x 28 mm study stent.Following post-dilatation, residual stenosis was noted to be 0%.The next day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient died.The cause of death was documented to be congestive heart failure.It was added that death certificate was unavailable and that the cause of death couldn't be confirmed beyond the obituary note.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7863851
• MDR Text Key: 119798097
• Report Number: 2134265-2018-60804
• 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: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 83 YR