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

Model Number H7493911428270

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

Patient Problems Arrhythmia (1721); Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)

Event Date 04/01/2017

Event Type  Death  

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 investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

Same case as mdr# 2134265-2017-11784 and 2134265-2017-11785.(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2012, the patient was referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion #1 was a de novo lesion which was total chronic occlusion located in the proximal left anterior descending artery (lad) with 100% stenosis and was 28 mm long with a reference vessel diameter of 3.00 mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.75 x 28 mm study stent (des).Following post dilatation there was 0 % residual stenosis.The target lesion #2 was a de novo lesion located in the mid lad with 80% stenosis and was 50 mm long with a reference vessel diameter of 2.25 mm.Target lesion #2 was treated with pre-dilatation and stent placement using a 2.25 x 24.00 mm study stent and a 2.25 x 28.00 study stent.Following post-dilatation, residual stenosis was 0%.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient presented to the hospital with complaints of palpitations with shortness of breath, chest heaviness along with cough.The patient reported that these symptoms started a week ago which then gradually worsened.On the same day, electrocardiography (ecg) revealed wide qrs tachycardia with occasional premature ventricular complexes, right bundle branch block (rbbb), left posterior fascicular block and t wave abnormality considerable to inferior ischemia.The patient was admitted to the emergency department (ed) for further care.The patient started on anti-dysrrhythmia since the subject had tachyarrhythmia.Chest x ¿ray revealed cardiomegaly and mild vascular congestion.It was also noted that the patient had elevated d dimer levels.Hence, a vq scan ventilation perfusion of the lung was ordered.Nuclear medicine (nm) lung scan revealed solitary large segmental mismatched defect in the medial segment of right middle lobe, intermediate probability of pulmonary embolus (pe).However, pe was ruled out.The patient was transferred to the hospital for further care.The patient was admitted to the hospital with the admission diagnosis of ventricular tachycardia (vt) and ventricular fibrillation (vfib) status post automated implantable cardioverter defibrillator (icd) firing and congestive heart failure (chf) exacerbation due to poor forward flow / acute systolic heart failure.It was reported that the subject also had acute kidney injury (aki).Mild troponin leak was also reported.After three days, an attempt was made to reset the patient's defibrillator; however, this was not successful due to subject's ventricular arrhythmias and device discharges.After six days, the patient underwent an ablation procedure; however, this procedure was also unsuccessful due to patient's hypotension.After two days, the investigator reported that the patient was offered an option to manage his cardiac arrhythmia with meds and re-programming icd, but the patient asked to turn off the icd.It was reported that the decision of the patient was discussed with the patient's spouse/family.Since all the close relatives of the patient agreed with the patient's decision.On the same day, the patient was discharged from the hospital and transferred to hospice care to turn off the icd.The patient expired at hospice care on the same day.Per the hospice note the patient had a diagnosis of unknown (primary) disease, obstructive sleep apnea, cardiomyopathy and end stage heart disease.The patient expired due to cardiac arrhythmia.Per pi note, the patient expired due to end stage heart disease.

Manufacturer Narrative

Describe event or problem, other relevant history and patient codes updated.(b)(4).

Event Description

It was further reported that the enlarged heart size was a result of patient's chronic heart failure.The mild troponin leak was due to stress test and was not a mi.The acute diagnosis of acute on chronic heart failure was a contributing factor to the hypotension and arrhythmias the patient experience.However, the site could not confirm which factors exacerbated the end stage heart disease leading to the death of the patient.

• 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: 7079019
• MDR Text Key: 93596310
• Report Number: 2134265-2017-11783
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729807926
• UDI-Public: 08714729807926
• 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: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2013
• Device Model Number: H7493911428270
• Device Catalogue Number: 39114-2827
• Device Lot Number: 15311499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2012
• 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; Hospitalization
• Patient Age: 66 YR