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

Model Number H7493911428300

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

Patient Problems Congestive Heart Failure (1783); Death (1802); Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Respiratory Distress (2045); Loss Of Pulse (2562)

Event Date 01/17/2014

Event Type  Death  

Event Description

(b)(4) clinical study.It was reported that acute respiratory insufficiency and death occurred.In (b)(6) 2013, clinical status assessment identified the patient's qualifying condition was unstable angina.The patient was also noted to have elevated biomarkers indicating ischemia prior to procedure and the patient was referred for urgent cardiac catheterization.Subsequently, the index procedure was performed.The target lesion was a long lesion located in the proximal left anterior descending (lad) extending to 1st diagonal with 80% stenosis and was 22 mm long with a reference vessel diameter of 3.00 mm.The lesion was treated with pre-dilatation and placement of a 3.00 x 28 mm study stent.Following post-dilatation, the residual stenosis was 0%.One day post procedure, the patient was discharged on dual anti-platelet therapy.In (b)(6) 2014, the patient was admitted from hospice care due to complaints of shortness of breath with acute exacerbation of congestive heart failure (chf).The patient had a long hospital course since (b)(6) 2013 and was in hospice care.The patient was noted to have elevated troponin levels; however, other cardiac biomarkers were within normal limits; and the isolated elevation was not considered to be due to acute coronary syndrome.The patient was started on treatment with lasix and antibiotics were continued.Chest x-ray revealed acute interstitial edema and pulmonary vascular congestion possibly related to chf.Electrocardiogram (ekg) revealed normal sinus rhythm (nsr), 1st degree atrioventricular (av) block and old left bundle branch block (lbbb).Three days after, the patient was diagnosed with acute respiratory insufficiency most likely secondary to chf with acute decompensation.The patient was then found to have no pulse or respiration.The patient was on do not resuscitate (dnr) status and the patient was pronounced dead at 10:55 pm on the same day.The cause of death was acute respiratory insufficiency.No autopsy was performed and the death certificate is not available.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint 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).

• Brand Name: PROMUS ELEMENT? PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4289928
• MDR Text Key: 18034296
• Report Number: 2134265-2014-07401
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2013
• Device Model Number: H7493911428300
• Device Catalogue Number: 39114-2830
• Device Lot Number: 15661570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR