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

Model Number H7493911328250

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

Patient Problems Death (1802); Myocardial Infarction (1969); Pneumonia (2011); Heart Failure (2206)

Event Date 01/21/2015

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause was unable to be determined.(b)(4).

Event Description

Promus element pmss clinical study: it was reported that cardiac infarction and death occurred.In (b)(6) 2011, the patient presented with unstable angina and index procedure was performed.The 99% stenosed, 24cmx2.5mm type c, diffuse target lesion was located in the moderately tortuous and moderately calcified right posterior descending artery(rpda).After pre-dilation, a 2.50x28mm promus element¿ was deployed at 12 atmospheres.Following post dilatation, residual stenosis was 0% with timi 3 flow.Three days post procedure, the patient was discharge.In (b)(6) 2015, the patient developed cardiac infarction, exacerbation of chronic cardiac failure and pneumonia.The physician performed percutaneous coronary intervention (pci) to treat the cardiac infarction and medications were also given to treat the cardiac failure and pneumonia.In (b)(6) 2015, the patient died and the cause of death is pneumonia.

• Brand Name: PROMUS ELEMENT ¿
• 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: 5091100
• MDR Text Key: 26289567
• Report Number: 2134265-2015-06416
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/29/2015

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 Model Number: H7493911328250
• Device Catalogue Number: 39113-2825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 75 YR