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

Model Number H7493911424350

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

Patient Problems Anemia (1706); Bradycardia (1751); Bronchitis (1752); Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Pneumonia (2011); Renal Failure (2041); Electrolyte Imbalance (2196); Chronic Obstructive Pulmonary Disease (COPD) (2237)

Event Date 01/13/2016

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

(b)(4) clinical study.It was reported that death occurred.In (b)(6) 2013, the patient presented due to unstable angina, myocardial infarction (mi) and was referred for cardiac catheterization.Subsequently, the index procedure was performed.Target lesion # 1 was a de novo lesion located in the proximal left anterior descending (lad) artery with 90% stenosis and was 20 mm long with a reference vessel diameter of 3.00mm.Target lesion # 1 was treated with direct placement of a 3.50 x 24 mm promus element¿ plus stent with 0% residual stenosis.Three days post index procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient presented to her local physician¿s office with complaints of progressive fluid volume overload and corresponding worsening shortness of breath consistent with an worsening of her chronic heart failure.Later, the patient was transferred to the local emergency department for further evaluation, where a brain natriuretic peptide (bnp) of greater than 5,000 and chest x-ray supported the presumed diagnosis of decompensated systolic heart failure and lab examination demonstrated acute renal failure with hyperkalemia secondary to decompensated heart failure.Subsequently, the patient was admitted for aggressive stabilizing therapy including aggressive iv diuresis, fluid volume restriction, iv steroids and antibiotics to treat possible pneumonia.Despite these measures; the patient had poor urine output and worsening creatinine clearance.In addition, the patient also had chronic obstructive pulmonary disease (copd) exacerbation/bronchitis and acute on chronic stage iii kidney failure secondary to decompensated heart failure, which were treated medically and 1 unit of prbcs was transfused for treating worsening anemia of chronic disease.One day post admission, the patient's overall condition worsened due to cardiovascular decompensation and associated compromise of renal perfusion.Discussions and preliminary arrangements were made to transfer the subject to rapid city regional hospital.In view of serious condition of the patient, discussion was made with the patient/ family members and the patient had a dnr/dni status but with daughter at bedside agreed to a brief period or resuscitation if necessary but not prolonged cpr or intubation.The patient subsequently experienced bradycardia in the 50¿s and then 30¿s which was treated with atropine and dobutamine infusion.Subsequently, the subject lost consciousness and pulses were no longer palpable.Code blue was called cardiopulmonary resuscitation (cpr) and lucas2 were initiated and external pacing was attempted with minimal success.Advanced cardiac life support (acls) protocols were utilized.Despite these efforts, the subject did not recover.After 45 minutes of cpr and discussions with immediate family members code blue was called off and cpr/ lucas2 was stopped.Life support systems and subsequent comfort care measures were also withdrawn.Upon examination, no spontaneous breathing or pulses were noted and the patient expired.Primary cause of death was "prolonged qt interval with bradycardia" and secondary cause of death was "end stage systolic congestive heart failure (chf) with acute decompensation¿.Contributing factors included acute renal failure (arf) on (chronic kidney disease (ckd)-iii with hyperkalemia, iron deficiency anemia, copd exacerbations, atrial fibrillation and uncontrolled on-insulin dependent diabetes mellitus (niddm).

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5464763
• MDR Text Key: 39193723
• Report Number: 2134265-2016-01878
• 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: 01/28/2016

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: 11/05/2013
• Device Model Number: H7493911424350
• Device Catalogue Number: 39114-2435
• Device Lot Number: 0015739512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2013
• 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