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

Model Number H7493952812350

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

Patient Problems Apnea (1720); Cardiac Arrest (1762); Death (1802); Dyspnea (1816); Myocardial Infarction (1969); Ventricular Fibrillation (2130); Loss of consciousness (2418); Loss Of Pulse (2562)

Event Date 05/31/2015

Event Type  Death  

Event Description

(b)(4) clinical study.It was reported that myocardial infarction and cardiac arrest occurred.In (b)(6) 2015, clinical assessment indicated that the patient's qualifying condition was stable angina.Subsequently, index procedure was performed.The target lesion was a de novo lesion located in the mid left anterior descending(lad) to the proximal lad with 60% stenosis and was 28 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation and placement of a 3.5x12mm promus premier¿ stent.Following post dilation, residual stenosis was 0%.One day post procedure, the patient was discharged on aspirin and clopidogrel.Ten days post procedure, the patient complained of shortness of breath and not feeling well.The patient was taken to the emergency room and it was then noted that the patient was unresponsive, apneic, and pulseless.The patient was intubated on arrival and resuscitation was started.Under examination, the patient was found to have a distended abdomen, pale, flushed skin, cool to the touch and a thready pulse.An automatic implantable cardiac defibrillator was present on the left side.The patient was shocked several times, but remained in ventricular fibrillation, despite resuscitation efforts.On that same day, the patient died of cardiac arrest secondary to complications of coronary artery disease.

Manufacturer Narrative

(b)(4).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 most probable root cause was unable to be determined.(b)(4).

• 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: 4954140
• MDR Text Key: 6635509
• Report Number: 2134265-2015-05014
• 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: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: H7493952812350
• Device Catalogue Number: 39528-1235
• Device Lot Number: 17523418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2014
• 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; Required Intervention
• Patient Age: 71 YR