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

Model Number H7493911408350

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

Patient Problems Death (1802); Dyspnea (1816); Non specific EKG/ECG Changes (1817); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Pulmonary Edema (2020); Respiratory Distress (2045); Ventricular Tachycardia (2132); Heart Failure (2206); Diaphoresis (2452); Loss Of Pulse (2562)

Event Date 09/01/2016

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 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

(b)(6) study.It was reported that the patient died.In (b)(6) 2013, the patient was diagnosed with unstable angina and coronary angiography was performed.The target lesion was a de novo lesion located in the proximal left circumflex artery (lcx) with 90% stenosis and was 8mm long with a 3.5mm reference vessel diameter.The target lesion was treated with pre-dilatation and placement of a 3.50x8mm promus element¿ plus stent, with 0% residual stenosis.The following day, the patient was discharged on clopidogrel.In (b)(6) 2016, the patient presented to emergency department with complaints of shortness of breath, diaphoresis and respiratory distress.Subsequently, the patient was intubated due to acute respiratory distress.After intubation, the patient remained normotensive and hypertensive for a short period of time, then became hypotensive and had runs of monomorphic ventricular tachycardia requiring multiple shocks via external pads.The patient was started on medication for ventricular tachycardia including intravenous (iv) bolus plus drip.Initial arterial blood gas (abg) was consistent with metabolic acidosis.Iv fluid was given in response to metabolic acidosis to assist the metabolic derangement.Chest x-ray showed some perihilar congestion consistent with pulmonary edema.Electrocardiogram (ekg) revealed t-wave inversions with no st-segment elevation myocardial infarction (nstemi).The troponin level was found to be 40 which was due to acute decompensated heart failure and no (nstemi) was noted.The patient was never hospitalized.On the same day, the patient lost pulse and cardiopulmonary resuscitation (cpr) was started with 6 rounds of epinephrine, given on subsequent rhythm and pulse checks.The patient had pulseless electrical activity (pea) arrest and h&ts were addressed.Multiple doses of bicarbonate were given.Ultrasound did not show any pericardial effusion.After pulses loss, the patient's condition was discussed with family and cpr was stopped.There were no pulses detected and pupils were fixed and dilated.The patient was pronounced dead.The cause of death was acute respiratory failure with hypoxia.

• 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: 6674324
• MDR Text Key: 78613707
• Report Number: 2134265-2017-06459
• 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: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2013
• Device Model Number: H7493911408350
• Device Catalogue Number: 39114-0835
• Device Lot Number: 15828010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2013
• 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: 67 YR