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

Model Number H7493911412300

Device Problem Occlusion Within Device (1423)

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Congestive Heart Failure (1783); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Reocclusion (1985); Pulmonary Edema (2020); ST Segment Elevation (2059); Thrombosis (2100); Ventricular Fibrillation (2130)

Event Date 12/16/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.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)(4) clinical study.It was reported that myocardial infarction (mi), in-stent thrombosis and cardiac arrest occurred.In (b)(6) 2013, clinical status assessment identified that the patient's qualifying condition as stable angina.Prior to the procedure, the subject underwent abnormal stress test or imaging test indicating ischemia and other objective evidence of ischemia.Subsequently, index procedure was performed.The target lesion was located in the mid left anterior descending (lad) with 80% stenosis and was 8 mm long with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 12 mm study stent.Following post-dilatation residual stenosis was 0%.The following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2016, the patient presented to non-study hospital with complaints of sudden onset of severe midsternal chest discomfort while trying to move a refrigerator and the patient was hospitalized on the same day.During his stay in er, the patient underwent electrocardiogram (ecg) on the same day which revealed sinus rhythm with anterior st elevation consistent with acute mi.The patient also underwent telemetry which revealed sinus rhythm.Subsequently, the patient was transferred to study hospital for cardiac catheterization.Upon examination, the patient was noted to be in severe distress secondary to chest pain.Of note, site has stated that "pi reviewed angiogram films and protocol definition to confirm that event was a very late stent thrombosis as timi flow of 0 with occlusion originating in the segment 5mm proximal to stent in the presence of thrombus along with new onset ischemic symptoms at rest and new ischemic ecg changes".Cardiac catheterization revealed 100% stenosis located in the mid lad extending to proximal lad of the previously placed study stent which was treated with pre-dilatation resulting in timi flow 2.Eventually thrombus was noted throughout the study stent.During the procedure, post pre-dilatation, the patient was noted to have ventricular fibrillation cardiac arrest which required external defibrillation as well as advanced cardiac life support (acls).The patient became hypotensive and treated with dopamine drip.Cardiac procedure was put on hold due to patient's unstable nature and was given zofran as a response to it.The patient was then stented with 3.25x33 non-bsc drug eluting stent.Immediately post stent deployment, repeat angiography revealed timi flow 3, patent proximal lad stent and 0% residual stenosis.The patient was elected for a balloon pump as the patient remained hypotensive requiring pressor therapy with large anterior mi.The patient was then transferred to cardiac intensive care unit and had developed pulmonary edema and mild congestive heart failure.During the patient¿s stay in hospital, he complained of abdominal discomfort and was ordered for ct of abdomen, which revealed no acute abnormality.It was felt that most of patient¿s discomfort was related to excessive gas.Five days after, the patient was discharged on home medications and was advised to follow up with his primary care physician to ensure that patient's renal function was stable.

• 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: 6826240
• MDR Text Key: 83835364
• Report Number: 2134265-2017-08673
• 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: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2013
• Device Model Number: H7493911412300
• Device Catalogue Number: 39114-1230
• Device Lot Number: 0015597831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR