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

Model Number H7493952824350

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

Patient Problems Chest Pain (1776); Death (1802); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Dizziness (2194)

Event Date 04/05/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

(b)(6) study.It was reported that the patient died.In (b)(6) 2015, clinical assessment indicated that the patient's qualifying condition was stable angina.The target lesion, a de novo lesion, was located in the proximal right coronary artery (rca) with 90% stenosis and was 22mm long with a reference vessel diameter of 3.5mm.There was mild vessel tortuosity.The target lesion was treated with pre-dilatation and a 3.50x24mm promus premier everolimus-eluting platinum chromium coronary stent.Post-dilatation was performed with 0% residual stenosis.Four days later, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient was awoken by substernal chest pain, which felt different than pain previously experienced.The patient did not use sublingual nitroglycerin at home, and called emergency medical services (ems).The patient's symptoms resolved after being placed on oxygen.The patient was hospitalized with complaints of shortness of breath and dizziness for an hour, abdominal pain, and right jaw pain.The patient denied exertional chest pain.The patent reported being compliant with dialysis treatments, anticoagulation and with all medications, although patient had not been able to complete his dialysis the day prior due to the abdominal pain.On admission, troponin levels were elevated, likely due to the patient's existing conditions of end stage renal disease (esrd) and congestive heart failure.Nt-probnp levels were also elevated.Treatment with antibiotics was planned.The patient received dopamine gtt.On the following day, cardiology was consulted due to the patient's elevated heart rate.The patient's heart rate increased to the 160s at times and then returned to normal sinus rhythm.Before the patient could be transferred to the intensive care unit (icu), the patient's mental status decreased and patient's heart rate went to a brady rhythm with couplets.The patient went into ventricular tachycardia rhythm followed by ventricular fibrillation with no pulse.Code blue was called and advanced cardiac life support (acls) protocol was initiated for 20 minutes without a return of spontaneous circulation.On the same day, the patient died due to an unknown cause of death.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that post index procedure, the patient was left with significant residual left main coronary and left circumflex artery lesions and received protected percutaneous coronary intervention (pci) with a non-bsc percutaneous ventricular assist device support with deployment of five stents in (b)(6) 2015.In (b)(6) 2016, the patient's systolic blood pressure was in the 80's and 90's.The patient was thought to be in the early stages of cardiogenic shock and it was felt best to manage medically given the patient's severe co-morbid conditions.The patient received dopamine.The following day, the patient developed worsening hypotension before going into ventricular tachycardia followed by ventricular fibrillation with no pulse.Although no ischemic changes were noted on the electrocardiogram (ecg), stent thrombosis was reported to be a possibility.Stent thrombosis could not be confirmed nor ruled out and a clear cause of death could not be confirmed because an autopsy was not performed.

• Brand Name: PROMUS PREMIER¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5607785
• MDR Text Key: 43628108
• Report Number: 2134265-2016-03623
• 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
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2016
• Device Model Number: H7493952824350
• Device Catalogue Number: 39528-2435
• Device Lot Number: 0017972738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 04/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2015
• 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: 61 YR