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

Model Number H7493952828350

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

Patient Problems Cardiac Arrest (1762); Death (1802); Dyspnea (1816); Myocardial Infarction (1969); ST Segment Elevation (2059); Ventricular Fibrillation (2130); Loss Of Pulse (2562); Complete Heart Block (2627)

Event Date 02/19/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Device is 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) clinical study.It was reported that cardiac arrest was experienced and the patient died.In may 2015, clinical assessment indicated that the patient's qualifying condition was stable angina.Subsequently, index procedure was performed.The target lesion, a de novo lesion, was located in the mid left anterior descending (lad) artery with 80% stenosis and was 28mm long with a reference vessel diameter of 3.5mm.The target lesion was treated with pre-dilatation and a 3.50mmx28mm promus premier drug-eluting stent was implanted.Post-dilatation was performed with 10% residual stenosis.A day after, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient experienced cardiac arrest, which was considered disabling and required hospitalization and medication (dobutamine).Electrocardiogram (ecg) findings revealed acute myocardial infarction/t elevation myocardial infarction (mi/stemi).The location of the mi was anterior (septal).The patient experienced shortness of breath, which began 6 hours prior to hospital admission.The patient was found to have a complete heart block.The patient was started on dobutamine which improved heart rate and blood pressure.Five days after, the patient had seized and went into an arrest.Initial rhythm was a ventricular fibrillation and the patient was shocked for a total of nine times without return of spontaneous circulation and pulseless electrical activity.At 12:49 the same day, the patient died and the cardiac arrest was considered fatal.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in 2015, myocardial perfusion imaging (mpi) was positive for moderate apical ischemia and was positive for intermediate risk.In (b)(6) 2016, the patient was found to have complete heart block with a slow idioventricular escape in the 40¿s.The assessment was beta blocker (bb) overdose versus inferior wall mi in the setting of elevated troponin.Nstemi was assessed as more likely with new complete heart block in the setting of elevated troponin and known residual rca disease.The patient was admitted to the coronary care unit (ccu) and started on dobutamine, which improved heart rate and systolic blood pressure to the 110¿s.Trans-venous pacing (tvp) was inserted at the bedside, with good capture.Imdur (isosorbide mononitrate), lisinopril, toprol xl (metoprolol tartrate), and lasix (furosemide) were withheld due to hemodynamic instability.Pci was deferred due to acute kidney injury (aki).A transthoracic echocardiogram (tte) showed an ejection fraction of 32%.Within the next two days, a non-sustained ventricular tachycardia (nsvt) was treated with a lidocaine drip.The patient was aggressively diuresed for fluid overload.During this time, troponins trended down and the complete heart block resolved.The lidocaine drip was discontinued on an unreported date.Two days after, the patient was transferred to a telemetry unit.The following day, the patient had a seizure.Treatment also included epinephrine x11 mg, 450 mg amiodarone (without return of spontaneous circulation and conversion), lidocaine 200 mg (without conversion), bicarbonate x2, calcium x2, and magnesium 2 gm.Persistent vfib became persistent pulseless electrical activity (pea).A cardiology fellow was present.The patient was assessed as not a candidate for ecmo (extracorporeal membrane oxygenation) by cardiothoracic services.A death certificate was not available.A brief narrative of events leading to death was signed and dated, and submitted in lieu of a death certificate.Per the discharge summary, the final diagnosis was cardiac arrest.Per the investigator, the primary cause of death was ventricular fibrillation.At the time of death, the myocardial infarction had not resolved.

• 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: 5768745
• MDR Text Key: 48729587
• Report Number: 2134265-2016-05788
• 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: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: H7493952828350
• Device Catalogue Number: 39528-2835
• Device Lot Number: 17778955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2015
• 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; Hospitalization
• Patient Age: 64 YR