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

Model Number H7493911412300

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

Patient Problems Dyspnea (1816); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); ST Segment Depression (2487)

Event Date 09/03/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per the product specifications.The most probable root cause is anticipated procedural complication as the reported event is due to a known physiological effect of the procedure noted within the product directions for use (dfu) and/or device labeling.(b)(4).

Event Description

(b)(6) clinical study.It was reported that following a coronary artery drug eluting stenting treatment procedure, the patient had myocardial infarction (mi).In (b)(6) 2012, the patient was diagnosed with stable angina (ccs classification: 3) and was referred for cardiac catheterization.The de novo target lesion was located in the proximal right coronary artery (prox rca) with 80% stenosis and was 10 mm long with a reference vessel diameter of 3.0 mm.The target lesion was treated with direct placement of a 3.00 x 12 mm promus element plus stent.Following post-dilatation, residual stenosis was 0%.The patient was discharged on aspirin and ticagrelor the next day.In (b)(6) 2017, the patient was presented to emergency department with shortness of breath and chest discomfort and the patient was referred for further evaluation.During the course at emergency department, the patient¿s pain returned.The patient¿s cardiac enzymes were noted to be elevated and the site reported an event of non st-elevation myocardial infarction (nstemi).Baseline enzymes were not withdrawn.Hence, the patient was admitted to the hospital for further diagnosis.During hospitalization the patient¿s shortness of breath worsened and the patient was diagnosed with acute exacerbation of chronic obstructive pulmonary disease (copd), anemia and thrombocytopenia.Further, the patient was referred for cardiac catheterization and possible intervention.Two days later, the 90% stenosis located in distal rca was treated with pre-dilatation and placement of a 2.75 x 28 mm non-bsc drug-eluting stent.Following post-dilatation, completion angiogram showed excellent results without thrombosis, perforation or dissection.The event was considered resolved and was recommended for cardiac rehabilitation.Two days later, the patient was discharged on aspirin and ticagrelor.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6930245
• MDR Text Key: 89026842
• Report Number: 2134265-2017-09889
• 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
• Type of Report: Initial
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2013
• Device Model Number: H7493911412300
• Device Catalogue Number: 39114-1230
• Device Lot Number: 0015337131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR