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

Model Number UNK758

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Death (1802); Dyspnea (1816); Reocclusion (1985); Pulmonary Edema (2020); Respiratory Distress (2045)

Event Date 12/15/2016

Event Type  Death  

Manufacturer Narrative

Device is a combination product.It is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-00167 and 2134265-2017-00168.(b)(4) clinical study.It was reported that angina was experienced and the patient died.In (b)(6) 2012, the patient presented due to unstable angina and myocardial infarction (mi).Cardiac catheterization was recommended.Four days after, index procedure was performed.Target lesion #1 was a de novo lesion located in the proximal left anterior descending (lad) artery with 85% stenosis and was 10mm long with a reference vessel diameter of 3mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.50x20mm promus element¿ plus stent, with 0% residual stenosis.Target lesion # 2 was a de novo culprit lesion for st-segment elevation myocardial infarction (stemi) located in the proximal right coronary artery (rca) with 90% stenosis and was 5mm long with a reference vessel diameter of 4.5mm.Target lesion #2 was treated with pre-dilatation and placement of a 4.00x16mm promus element¿ plus stent.Following post dilatation, the residual stenosis was 0%.On the following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, a promus premier¿ drug-eluting stent was implanted in mid lad.In (b)(6) 2016, at 9:00 hrs, the patient developed intermittent sharp precordial chest pain.The symptoms lasted no more than an hour at a time and were 8/10 at maximum intensity.The patient denied associated radiation of pain, diaphoresis or nausea.The patient's complexion was noted as pale greenish by a family member.The patient had 2/6 systolic murmur, peripheral edema, back pain aggravated by ct scan but rales were heard.The patient showed slightly elevated (0.207) troponin t (reference range less than 0.010).The patient was diagnosed with cardiac angina and was hospitalized on the same day.Seven days post hospitalization, coronary angiography revealed 90% proximal in-stent restenosis of the lad study stent.On the same day, the patient underwent 3 vessel coronary artery bypass graft (cabg) including left internal mammary artery (lima) to lad, saphenous vein graft (svg) to left posterior descending artery (l-pda), and svg to obtuse marginal (om).On post-operative day two, intra-aortic balloon pump (iabp) was removed.On day four, there was an increase of vasopressor need that necessitated escalation of support and a non-bsc heart pump was positioned.The patient improved with ability to decrease some support over the subsequent 48 hours.The patient received intermittent hemodialysis.Despite of prolonged hemodialysis and 3l/min support, the patient did not show any improvement.The patient started showing signs of liver failure, hypoxemia, acute respiratory distress syndrome, necessitating bag ventilation for adequate oxygenation.The patient received bicarbonate iv boluses for worsening metabolic acidosis and required blood products for severe coagulopathy and hemolysis.The family of the patient wished to proceed with withdrawal of extracorporeal membrane oxygenation (ecmo).Eight days post-operation at 7:07, the patient expired.The cause of death was "cardiac angina".Per death certificate, immediate cause of death was liver failure and acute respiratory distress syndrome.Other underlying causes were cardiogenic shock, acute on chronic heart failure and ischemic heart disease.

Manufacturer Narrative

Describe event or problem, relevant tests/lab data and patient codes updated.(b)(4).

Event Description

It was further reported that on (b)(6) 2016, the patient presented to emergency department with complaints of dyspnea on exertion.Initial ekg revealed paced rhythm and chest x-ray revealed cardiomegaly and diffuse bilateral pulmonary edema.Ct angio pulmonary revealed no evidence for pulmonary embolism.Subsequently subject was referred for cardiac catheterization.An intra aortic balloon pump (iabp) was placed in anticipation of coronary artery bypass graft (cabg).One day post-cabg, the patient continued with inotropic and vasopressor drop support in addition to iabp.On post-operative day 3, the patient continued to remain stable with multiple vasopressor and inotropic support.

• Brand Name: PROMUS PREMIER¿
• 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: 6278652
• MDR Text Key: 65768257
• Report Number: 2134265-2017-00169
• 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,Followup
• Report Date: 01/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• 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: 71 YR