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

Model Number 9307

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

Patient Problems Death (1802); Pneumonia (2011)

Event Date 12/29/2015

Event Type  Death  

Manufacturer Narrative

Device is combination product.

Event Description

(b)(6) clinical study.It was reported that the patient experienced pneumonia and died.In (b)(6) 2013, the patient was referred for cardiac catheterization and index procedure was performed.The target lesion #1 was located in the mid right coronary artery (rca) with 80% stenosis, and was 20 mm long with a reference vessel diameter of 4.0 mm.The target lesion #1 was treated with pre-dilatation, and placement of 4.00x20mm study stent.Following post dilatation residual stenosis was 0%.Few days after, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient was hospitalized for bilateral pneumonia and cardiac enzymes elevation.The patient was diagnosed with myocardial infarction located in anterior (septal) and inferior, considered by the physician as not related to the study stent.In (b)(6) 2015, the events were considered to be recovered/resolved and the patient was discharged on the same day.Seventeen days later, the patient died.No action was taken at the time of death.

• Brand Name: PROMUS ELEMENT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8174189
• MDR Text Key: 130659470
• Report Number: 2134265-2018-63969
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2014
• Device Model Number: 9307
• Device Catalogue Number: 9307
• Device Lot Number: 0015884023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2013
• 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