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

Model Number H7493911428300

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

Patient Problems Bronchitis (1752); Death (1802); Dyspnea (1816); Pneumonia (2011)

Event Date 10/12/2014

Event Type  Death  

Event Description

(b)(4) clinical study.It was reported that death occurred.In (b)(6) 2012, the patient presented due to unstable angina and cardiac catheterization was recommended.Subsequently, coronary angiography and the index procedure were performed.The target lesion was a de novo lesion located in the proximal left circumflex (lcx) artery with 99% stenosis and was 26 mm long with a reference vessel diameter of 3.0 mm.Target lesion was treated with pre-dilatation and placement of the 3.00x28mm promus element¿ plus sent.Following post dilatation, residual stenosis was 0%.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient expired at home.

Event Description

It was further reported that in (b)(6) 2014, the patient had increased shortness of breath and was diagnosed with acute bronchitis/aspiration pneumonia.Patient was negative for chest pain or other cardiac complications.Three days after, patient complained of leg pain/restlessness; hospice care and morphine was then started and later expired.In addition, as per death certificate, the immediate cause of patient's death is coronary artery disease (cad) and autopsy was not performed.

Manufacturer Narrative

Device is a combination product.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).

Manufacturer Narrative

Describe event or problem and patient codes- updated.(b)(4).

• Brand Name: PROMUS ELEMENT? PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4247823
• MDR Text Key: 5015457
• Report Number: 2134265-2014-07032
• 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,Followup
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2012
• Device Model Number: H7493911428300
• Device Catalogue Number: 39114-2830
• Device Lot Number: 14977582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2012
• 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: 72 YR