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

Model Number	H7493911420300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Dyspnea (1816); Myocardial Infarction (1969)
Date of Event	01/13/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
Event or Problem Description
(b)(6) clinical study.It was reported that myocardial infarction occurred and the patient died.In (b)(6) 2013, the patient presented with stable angina and was referred for cardiac catheterization.The target lesion was located in the mid left anterior descending artery (lad) with 75% stenosis and was 12 mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with pre-dilatation and placement of a 3.00 x 20 mm study stent and the residual stenosis was 0%.One day post procedure, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient presented with the complaints of shortness of breath for two weeks and was hospitalized on the same day.Cardiac enzymes were found to be elevated.Electrocardiogram (ecg) revealed a-v block, wide qrs intervals with left bundle branch block and ct revealed pulmonary edema and bilateral effusions.Chest x-ray revealed bilateral pleural effusion and basilar airspace disease with stable hilar and perihilar opacities.The patient was diagnosed with acute on chronic combined systolic and diastolic congestive heart failure (chf), acute hypoxic respiratory failure and pulmonary edema.The patient was placed on diuresis and was given lasix for the treatment of respiratory failure.The patient was noted to be hypotensive and hypoxic with increasing oxygen requirements and was transferred to intensive care unit (icu) for further management.The following day, the patient was intubated due to acute combined hypoxic and hypercarbic respiratory failure.Repeat x-ray revealed vascular and pleural effusions.The patient expired due to severe cardiogenic shock.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7465800
• Report Number: 2134265-2018-03614
• Device Sequence Number: 1543069
• Product Code: NIQ
• UDI-Device Identifier: 08714729807964
• UDI-Public: 08714729807964
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2013
• Device Model Number: H7493911420300
• Device Catalogue Number: 39114-2030
• Device Lot Number: 15615513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 89 YR