MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; STENT, CORONARY, DRUG-ELUTING

Model Number UNK717

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

Patient Problems Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Edema (1820); Myocardial Infarction (1969)

Event Date 01/04/2018

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: the device was not returned for analysis.The investigation conclusion was unable to be determined.(b)(4).

Event Description

Same case as mdr id 2134265-2018-04061 and 2134265-2018-04062.Promus element plus clinical study.It was reported that non-st elevation myocardial infarction (nstem) and death occurred.In (b)(6) 2013, the patient presented due to unstable angina and myocardial infarction.Subsequently, angiography and the index procedure were performed.Target lesion #1 was located in the proximal segment (ostial lesion) of saphenous vein graft (svg) to right posterior descending artery (rpda) with 80% in-stent restenosis (isr) of a previously deployed unknown drug-eluting stent (des) and was 35mm long with a reference vessel diameter of 3.5mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.50 x 38mm promus element plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.Target lesion #2 was a de novo lesion located in the mid segment of svg to rpda with 70% isr of a previously deployed unknown des and was 35mm long with a reference vessel diameter of 3.0mm.Target lesion #2 was treated with direct stent placement using a 3.00 x 38mm promus element plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.Target lesion #3 was a de novo lesion located in the distal segment of svg to rpda with 90% stenosis and was 6mm long with a reference vessel diameter of 3.0mm.Target lesion #3 was treated with direct stent placement using a 3.00 x 8mm promus element plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.On the following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2018, the patient presented with complaints of lower extremity edema and shortness of breath.An elevation in cardiac enzyme was noted.The patient was diagnosed with nstemi and referred to the hospital for further evaluation.The patient had code status of do not resuscitate (dnr) and as the patient had a risk of renal failure (esrd secondary to lupus nephritis status post renal transplant) coronary angiogram was deferred.It was decided to treat the nstemi medically and to provide comfort care to the patient.During the hospitalization the patient had atrial fibrillation which was treated with medications, severe metabolic acidosis which was treated with electrolyte replacement and anemia with hemoglobin.No medications were given in response to nstemi.Eleven days after, the event nstemi was considered to be resolved.On the same day the patient was discharged from the hospital and was transferred to the transitional care unit (tcu) for continued rehab with palliative care.In (b)(6) 2018 while in tcu the patient's health started to decline due to worsening heart failure and the patient was placed on hospice care.It was reported that the patient was brought home and on the next day, the patient was found expired at home.The patient expired due to worsening heart failure.The cause of death was congestive heart failure.

• Brand Name: PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7500152
• MDR Text Key: 107778362
• Report Number: 2134265-2018-04060
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2018
• 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): Death
• Patient Age: 68 YR