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

Model Number H7493911432250

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

Patient Problems Cardiac Arrest (1762); Death (1802); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Occlusion (1984); Ischemic Heart Disease (2493)

Event Date 07/05/2015

Event Type  Death  

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

Event Description

Same case as mdr id (b)(4).Promus element plus clinical study it was reported that death occurred.In (b)(6) 2012, the patient was referred for cardiac catheterization.Coronary angiography and the index procedure were performed.Target lesion # 1 was a long de novo lesion located in the proximal right coronary artery (rca) and extending to the mid rca with 90% stenosis and was 50mm long with a reference vessel diameter of 3.0mm.The lesion was treated with pre-dilatation and placement of a 2.50mmx32mm promus element⠐lus stent which was overlapped proximally with a 3.00mmx32mm promus element⠐lus stent, resulting in 0% residual stenosis.In addition, mid left anterior descending artery (lad) was also treated medically.Nine days post procedure, the patient was discharged on clopidogrel.In (b)(6) 2015, the patient expired.The cause of death was myocardial infarction and no specific action was taken to treat the event.Per death certificate, the immediate cause of death was heart attack and the secondary causes were ischemic heart disease, hypertension, dyslipidemia and lung cancer.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2015, the patient presented with cardiopulmonary arrest to emergency room (er) via emergency medical service (ems).Pre-arrival treatment included cardiopulmonary resuscitation (cpr), intubation, epinephrine bicarbonate, and the risk factors assessed were chronic obstructive pulmonary disease (copd) and lung cancer.In addition, patient's autopsy report revealed, pulmonary non small cell lung cancer, copd metastatic carcinoma involving the left frontal lobe of the brain and also there was a 95% occlusion at the right coronary artery (rca) status post stenting,80% occlusion at left anterior descending (lad).No infarcts or other lesions were noted.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5001507
• MDR Text Key: 22895942
• Report Number: 2134265-2015-05324
• 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
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2013
• Device Model Number: H7493911432250
• Device Catalogue Number: 39114-3225
• Device Lot Number: 15144718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2012
• 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: 73 YR