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

Model Number H7493911428250

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

Patient Problems Chest Pain (1776); Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Hyperglycemia (1905); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Pulmonary Edema (2020); Respiratory Distress (2045); Loss Of Pulse (2562)

Event Date 01/29/2016

Event Type  Death  

Manufacturer Narrative

Device is a 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).

Event Description

Same case as mdr id: 2134265-2016-01716 promus element plus clinical study.It was reported that myocardial infarction (mi), congestive heart failure exacerbation and death occurred.In (b)(6) 2013, the patient was diagnosed with mi and unstable angina.The patient was subsequently recommended for cardiac catheterization.Target lesion #1 was a de novo lesion located in the proximal portion of saphenous vein grafts (svg) to first obtuse marginal (om), with 99 % stenosis and was 26mm long with a reference vessel diameter of 2.50mm.Target lesion #1 was treated with thrombectomy and direct stent placement using a 2.50x28mm promus element plus drug-eluting stent with 0% residual stenosis.Target lesion #2 was an in-stent restenosis (isr) of non-bsc drug-eluting stent located in the mid right coronary artery (rca) with 95% stenosis and was 10mm long with a reference vessel diameter of 2.50mm.Target lesion #2 was treated with direct stent placement using a 2.25x12.00mm promus element plus drug-eluting stent with 0% residual stenosis.One day after post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient presented to opc due to episodes of shortness of breath and chest pressure.It was noted that subject had elevated blood sugar and edema of lower extremities for which single dose of lasix was given.On the following day, the patient was followed up with the physician and noted that there was no improvement of the edema in lower extremities.Subsequently, the patient was referred for inpatient care on the same day with the diagnosis of congestive heart failure, poorly controlled insulin dependent diabetic mellitus and chronic renal insufficiency.The patient was also noted to have the signs of anemia which was treated with blood transfusion.Three days after, the patient was feeling better and denies shortness of breath and chest pain.Per physician's impression, the acute mi is cause of her congestive heart failure.So, the patient was referred for another hospital as there is a possibility that mi could end up her heart function.On the same day, the patient was transferred to another hospital and was subsequently referred for coronary angiography to rule out coronary artery disease (cad).In (b)(6) 2016, coronary angiography revealed discrete proximal lesion and 99% stenosis in mid rca and was treated with placement of 2.75x16 bare metal stent, with 0% residual stenosis.On the next day, the events were considered resolved and the patient was discharged on aspirin and clopidogrel.On the same day, the patient presented to emergency room (er) with the chief complaint of substernal chest pain and shortness of breath.Chest x-ray was performed and revealed pulmonary edema and findings suggestive of congestive heart failure (chf).Subsequently, the patient was admitted to intensive care unit (icu) with chf exacerbation on the same day.The patient was hypotensive with systolic blood pressure (sbp) in 70's and was subsequently placed on pressors.The patient was further intubated to support her respiratory distress.Due to weak contractility of the heart, patient went in to pulseless electrical activity (pea).Subsequently, she was started on cardiopulmonary resuscitation (cpr) due to loss of pulse.The patient was not responsive to advanced cardiac life support (acls) protocol.Seven days after, the patient expired.The primary cause of death is congestive heart failure exacerbation.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that per death certificate, the primary cause of death was "chest pain with acute cardiac arrest" and secondary causes were "cardiogenic shock" and coronary artery disease mitral regurgitation".The underlying significant cause contributing to death was "congestive heart failure".It was also reported that autopsy was not performed.

• 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: 5503658
• MDR Text Key: 40409041
• Report Number: 2134265-2016-01715
• 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: 02/17/2016

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: 06/28/2013
• Device Model Number: H7493911428250
• Device Catalogue Number: 39114-2825
• Device Lot Number: 15445036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2012
• 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): Death
• Patient Age: 61 YR