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

Model Number H7493911412250

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

Patient Problems Cardiomyopathy (1764); Chest Pain (1776); Death (1802); Dyspnea (1816); Occlusion (1984); Heart Failure (2206); Multiple Organ Failure (3261)

Event Date 03/02/2014

Event Type  Death  

Event Description

(b)(4).It was reported that chest pain, shortness of breath, heart failure, restenosis, and patient death occurred.On (b)(6) 2013, the subject presented due to stable angina and was referred for cardiac catheterization.The index procedure was performed.Target lesion # 1 was a de novo lesion located in the proximal left circumflex (lcx) with 80% stenosis and was 10 mm long with a reference vessel diameter of 2.4 mm.Subsequently, the lesion was treated with pre-dilatation and placement of a 2.50 x 12 mm promus element plus, with 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.On (b)(6) 2014,the subject experienced due to chest pain and shortness of breath related to heart failure.One day post onset of symptoms, the subject was hospitalized.The subject was inserted with a central line access for renal replacement therapy and was treated with medication.Coronary artery bypass graft (cabg) was performed to treat left internal mammary artery (lima) to left anterior descending (lad) artery; sequential vein graft to diagonal and obtuse marginal branch (om).Ten days post procedure, the patient expired.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was further reported that pre-existing thrombus was noted during the index procedure.In (b)(6) 2014, the significant stenosis was treated with coronary angiography without revascularization.At the time of event, patient antiplatelet medication was last taken on (b)(6) 2014.In (b)(6) 2014, the physician performed 4x vessel coronary artery bypass graft (cabg) was performed.Saphenous vein graft (svg )to optional diagonal (od) ramus and svg to obtuse marginal (om).The immediate cause of death was cardio-pulmonary arrest and not cardiac arrest alone as previously reported.

Manufacturer Narrative

Describe event or problem updated.(b)(4).

Event Description

It was further reported that prior to the index procedure, that patient also presented with silent ischemia and abnormal stress test.In unspecified date, the patient underwent catheterization and re-evaluation which revealed significant stenosis.The stenosis was not thought amendable to intervention and it was felt that there was no need to perform an intervention at that time.However, due to persistent symptoms of shortness of breath (sob) and congestive heart failure (chf) like symptoms and upon further consultation, cardiac surgery was recommended.On (b)(6) 2014,the patient also presented with vomiting and for preoperative cardiac workup for recommended cardiac surgery.At presentation, the patient was also showing chf like symptoms with mild flash pulmonary edema and chronic kidney disease nitric oxide synthase (nos).Prior to hospitalization, the patient was having periods of shortness of breath and coughing up of some phlegm which was often revealed by nitroglycerin.The consultation for chronic kidney disease (ckd) confirmed acute kidney injury (aki), ckd, nos along with hypokalemia, hypomagnesemi and patient's troponin levels increased to 0.048.Electro cardiogram (ecg) revealed marked sinus bradycardia with occasional pvc¿s.The pre-operative diagnosis included unstable angina and occlusive coronary arteriosclerosis with dissected left main.Pre-operative ejection fraction was 20-25%.In addition, the patient required an intraaortic balloon pump placement in order to maintain systemic pressure.Post-pump lvef improved to 40%.The overall transesophageal echo showed improvement in biventricular function.A central venous line was placed considering patient¿s renal condition.The patient was also started on continuous renal replacement therapy (crrt).Fourteen days post procedure, the patient died.The immediate cause of death was cardiac arrest secondary to cardiac failure.No autopsy was performed.It was stated in the death certificate that the primary cause of death was multisystem organ failure.The underlying conditions that were responsible for the subject¿s death were malignant pulmonary hypertension, cardiomyopathy and coronary artery disease (cad).

Manufacturer Narrative

Event date corrected from (b)(6) 2014.(b)(4).

• Brand Name: PROMUS ELEMENT? PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3789659
• MDR Text Key: 4436493
• Report Number: 2134265-2014-02386
• 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,Followup
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2013
• Device Model Number: H7493911412250
• Device Catalogue Number: 39114-1225
• Device Lot Number: 15136870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 81 YR