MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE PROMUS ELEMENT? PLUS; STENT, CORONARY, DRUG-ELUTING

Model Number H7493911620250

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

Patient Problems Atrial Fibrillation (1729); Cardiomyopathy (1764); Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Mitral Regurgitation (1964); Pleural Effusion (2010); Pneumonia (2011); Renal Failure (2041); Tricuspid Regurgitation (2112); Respiratory Failure (2484)

Event Date 05/14/2014

Event Type  Death  

Event Description

Same case as mdr id: 2134265-2015-04254 and 2134265-2015-04255.(b)(4).It was reported that acute respiratory failure and death occurred.In (b)(6) 2012, the patient presented due to chest pain and was hospitalized on the same day.The patient was diagnosed with non-st elevation myocardial infarction (nstemi).Subsequently, coronary angiography and index procedure were performed.The target lesion #1 was located in the proximal portion of saphenous venous graft (svg) to obtuse marginal (om1) with 90% in-stent restenosis of an unknown drug eluting stent (des) and was 32 mm long with a reference vessel diameter of 3.5 mm.The lesion was treated with pre-dilatation and placement of a 3.5x38 mm promus element¿ plus stent, resulting in 0% residual stenosis.The target lesion #2 was located at the anastomotic site in the distal portion of svg to om1 with 70% in-stent restenosis of an unknown des and was 8 mm long with a reference vessel diameter of 2.75 mm.The lesion was treated with pre-dilatation and placement of a 2.75x12 mm promus element¿ plus stent, resulting in 0% residual stenosis.The target lesion #3 was located in the native om1 distal to the anastomotic site with 90% in-stent restenosis of a n unknown des and was 16 mm long with a reference vessel diameter of 2.5 mm.The target lesion was treated with pre-dilatation and placement of a 2.50x20mm promus element¿ plus stent, resulting in 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient presented with 1 week history of progressive shortness of breath (sob), dyspnea on exertion and was subsequently diagnosed with acute respiratory failure secondary to congestive heart failure (chf) exacerbation.Patient's electrocardiogram (ecg) revealed atrial fibrillation, bifascicular block and non-specific st and t wave changes and the patient had acute on chronic combined systolic and diastolic congestive heart failure due to ischemic cardiomyopathy.Patient's computed tomography (ct scan) revealed bilateral pleural effusions and pneumonia due to right lung consolidation which placed patient on doxycycline and rocephin.The patient also had acute renal insufficiency, possibly meeting the criteria for acute renal failure with chronic kidney disease (ckd) stage iii/iv and was found to be anemic due to chronic diseases.On the following day, an echo was performed which revealed moderate mitral regurgitation, tricuspid regurgitation, pulmonary hypertension and dilated right ventricle with severely depressed right ventricular systolic function.The patient was planned to be sent to hospice care due multi-system organ failure and also, a do not resuscitate (dnr) was initiated.Patient was discharged on aspirin and clopidogrel on the following day.Four days later, the patient expired at home and the cause of death is acute respiratory failure.

Manufacturer Narrative

Device is combination product.Device evaluated by mfr: 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).

• Brand Name: PROMUS ELEMENT? PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4895975
• MDR Text Key: 6019432
• Report Number: 2134265-2015-04256
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2012
• Device Model Number: H7493911620250
• Device Catalogue Number: 39116-2025
• Device Lot Number: 14814871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2011
• 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: 72 YR