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

Model Number H7493911428300

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

Patient Problems Anemia (1706); Congestive Heart Failure (1783); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Ischemia (1942); Myocardial Infarction (1969); Pulmonary Edema (2020); Renal Failure (2041); Respiratory Failure (2484)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id# 2134265-2017-01655.(b)(4).It was reported that the cec adjudicated this event as non-st segment elevation myocardial infarction (nstemi).In (b)(6) 2012, the patient presented due to stable angina and was referred for cardiac catheterization.Subsequently, index procedure was performed on the same day.The target lesion was a de novo and ostial lesion located in the proximal lad extending to mid lad with 70% stenosis and was 50 mm long with a reference vessel diameter of 3.50 mm.The target lesion was treated with direct placement of a 3.50x28mm promus element¿ plus stent and a 3.00x28mm promus element¿ plus stent in overlapping manner.Following post-dilatation, the residual stenosis was 0%.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient presented to the emergency room with shortness of breath and chest pressure.Her symptoms being constant have fluctuated in intensity.The course/duration of symptoms was worsening.She was found to be in acute pulmonary edema with acute respiratory failure complicated by anemia.Subsequently, patient was also diagnosed with hypertensive crisis, congestive heart failure (chf) exacerbation and acute renal failure.Electrocardiogram (ecg) revealed non specific intraventricular conduction delay with left ventricular hypertrophy (lvh) with strain pattern.There were anterior q waves without convincing evidence to suggest an st segment elevation myocardial infarction (stemi).Chest x-ray revealed cardiomegaly with bilateral pulmonary edema.The following day, ecg revealed st and t wave abnormality, consider inferior ischemia and anterolateral ischemia.Cardiac enzymes were found to be elevated and site reports an event of mi.Subsequently, cardiac catheterization was recommended.The patient was placed on a lasix drip for her longstanding history of renal failure.The patient continued to improve, was able to be transitioned off a lasix drip on to oral diuretics and had her hypertensive medications adjusted in order to continue to improve her cardiomyopathy and her systolic and diastolic dysfunction.The patient after diuresing had her acute respiratory failure and acute pulmonary edema resolved.In (b)(6) 2016, the patient underwent left heart catheterization showing previously placed lad stents were widely patent, no significant main branch obstructive coronary artery disease (cad), severe diffuse distal "pruning" of the entire branch vessel vasculature, preserved lv systolic function.In view of her catheterization, no disease amenable to percutaneous coronary intervention (pci) or coronary artery bypass grafting (cabg) was recommended and therefore aggressive medical management was initiated.After seven days, the events were considered resolved and subject was discharged on aspirin.

• Brand Name: PROMUS ELEMENT¿ PLUS
• 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: 6386356
• MDR Text Key: 69322954
• Report Number: 2134265-2017-01657
• 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: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2013
• Device Model Number: H7493911428300
• Device Catalogue Number: 39114-2830
• Device Lot Number: 15352658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2012
• 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): Required Intervention
• Patient Age: 55 YR