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

Model Number H7493911420250

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Thrombosis (2100); Cardiac Tamponade (2226); Cardiogenic Shock (2262)

Event Date 08/24/2017

Event Type  Death  

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 investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-12810, 2134265-2017-12809 and 2134265-2017-12808.(b)(4) clinical study.It was reported that the patient died.In (b)(6) 2012, the patient presented with unstable angina.Coronary angiography and index procedure were performed.Target lesion was an in-stent restenosis (isr) of bare metal stent located in mid right coronary artery (rca) with 99% stenosis and was 52mm long with a reference vessel diameter of 2.5mm.The lesion was treated with pre-dilatation and placement of a 2.50mm x20mm and 2.75mm x38mm promus element¿ plus stents in an overlapping manner.Following post dilatation resulting in 0% residual stenosis.The target lesion #2 was an in-stent restenosis of bare metal stent located in the mid left anterior descending (lad) with 95% stenosis and was 44mm long with a reference vessel diameter of 2a.5mm.The lesion was treated with direct stent placement using a 2.50x38.00 mm and 2.75x12.00mm promus element¿ plus stents resulting in residual 0% stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient expired and the cause of death was unknown.

Manufacturer Narrative

Describe event or problem, relevant tests/lab data updated.Event date corrected from (b)(6) 2017 to (b)(6) 2017.(b)(4).

Event Description

In (b)(6) 2017, the patient presented with abdominal pain in right upper quadrant and pancytopenia and was hospitalized on the same day.Results from a ct scan of the abdomen suggested appendicitis so a laparoscopic appendectomy was performed.The event was considered resolved and the subject was discharged on the same day.Eight days later, the patient presented with general weakness and severe hypotension.Electrocardiography (ekg) showed acute inferior wall myocardial infraction.Angiography revealed 100% occlusion, stent thrombosis, in the right coronary artery (rca).On the same day, the patient was diagnosed with cardiogenic shock and was placed on intra-aortic balloon pump in response to this event.The 100% occlusion in mid rca, stent thrombosis, was treated with balloon angioplasty using 2.5 x 12 mm balloon followed by placement of a 2.25 x 32 mm synergy stent in the distal rca with 0% residual stenosis timi flow 3.The 100% occlusion was considered resolved.The next day, the patient continued to have right ventricle infarction with hypotension requiring fluids and pressors support.The patient was transferred to the intensive care unit (icu).In icu the patient was found to have acute tubular necrosis from chronic hypotension, shock liver, and metabolic acidosis.The patient had pericardial tamponade and underwent pericardiocentesis.Four days later, the patient was diagnosed with acute metabolic encephalopathy.Two days later, on (b)(6) 2017, echocardiography revealed new onset of left ventricular defect (vsd) and left ventricle (lv) aneurysm.In (b)(6) 2017, the acute inferior wall myocardial infarction was considered to be resolved.On the same day, the patient had chest pain and was transferred to a different facility for further care.The patient underwent cardiac catheterization which revealed patent stents in the rca and left anterior descending artery (lad).The patient was diagnosed with left ventricular pseudoaneurysm and underwent ventricular septal defect/pseudoaneurysm repair in response to this event.The patient was diagnosed with new onset atrial fibrillation with rapid ventricular rate.The next day, the event s left ventricular pseudoaneurysm was considered to be resolved.Two days later, the patient underwent two unsuccessful cardioversion and medication therapies in response to the event of new onset atrial fibrillation.Three days later, the patient was unresponsive to questions and gaze deviated to left.The patient was diagnosed with seizure and received medications in response to this event.A ct scan revealed moderate diffuse cortical atrophy a subtle lucency in the right frontal lobe.The event was considered resolved.The patient was diagnosed with ischemic bowel: extensive necrosis small intestine and underwent exploratory laparotomy with multiple resections.The next day, the patient was started on comfort care measures as per family¿s decision.The same day the patient died due to circulatory shock.The patient had post-operative complications which led to cardiogenic and septic shock.An autopsy was not performed.

Manufacturer Narrative

Describe event or problem updated.(b)(4).

Event Description

It was further reported that the exact cause of death was cardiogenic shock and septic shock and not circulatory shock as what was previously reported.Per death certificate the cause of death was septic shock.

Manufacturer Narrative

Describe event or problem updated.(b)(4).

Event Description

It was further reported that the secondary cause of death were acute postoperative respiratory failure, ischemic hepatitis and non-st elevation myocardial infarction.The expiration note at the time of death, the subject was unresponsive with no spontaneous motor activity, no breath sounds or heart sounds for 1 minute, no corneal reflex and no electrical activity on electrocardiogram.

• 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: 7136146
• MDR Text Key: 95445354
• Report Number: 2134265-2017-12801
• 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,Followup,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2013
• Device Model Number: H7493911420250
• Device Catalogue Number: 39114-2025
• Device Lot Number: 15460884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2012
• 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: 62 YR