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 Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Fatigue (1849); Myocardial Infarction (1969)

Event Date 07/04/2016

Event Type  Death  

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 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

Same case as mdr id: 2134265-2016-06787.(b)(6).It was reported that myocardial infarction (mi) occurred and the patient died.In (b)(6) 2013, the patient presented due to shaking chills, fever and was diagnosed with utt.In the course of evaluation, the patient was found to have a significant cardiac enzyme leak and the patient was referred for cardiac catheterization.Subsequently, index procedure and coronary angiography were performed.Target lesion #1 was a denovo located in the mid left anterior descending (lad) with 80% stenosis and was 8mm long with reference vessel diameter of 3.0mm.Target lesion #1 was treated with direct placement of 3.00x12mm promus element¿ plus drug-eluting study stent.Following post-dilatation, residual stenosis was 0%.Target lesion #2 was a de novo located in the 3rd obtuse marginal (om) with 60% stenosis and was 10mm long with reference vessel diameter of 2.5mm.Target lesion #2 was treated with direct placement of 2.50x12mm promus element¿ plus drug-eluting study stent with 0% residual stenosis.However, post deployment of study stent, a moderate amount of spasm was noted in proximal om which was treated with intracoronary nitroglycerin.The following day, the patient was discharged on clopidogrel and aspirin.In (b)(6) 2016, the patient presented with complaints of shortness of breath with increased leg swelling and increasing weakness and was hospitalized on the same day.During the course of hospitalization, the patient was diagnosed with myocardial infarction and pulmonary edema.Electrocardiogram (ecg/ekg) revealed inferior-lateral mi.The patient was diagnosed with acute heart failure with right pleural effusion.The following day, cardiac enzymes were noted to be elevated and ekg did not show st elevation.Subsequently, the patient was referred for cardiac catheterization.Four days after, the patient was diagnosed with respiratory failure, bilateral pleural effusions, and delirium tremens.Nine days after, the patient experienced ventricular fibrillation with rapid ventricular response.Subsequently, medical therapy was initiated and angiography without revascularization was performed.On the same day, the event was considered as resolved.Twelve days after, patient was diagnosed with rectus sheath hematoma and blood was transfused in response to the event.The event was considered as not resolved/not recovered.Eighteen days after, the patient underwent cardiac catheterization and the 5.0mm non-bsc microaxial, catheter-mounted pump was positioned in the left ventricle (lv) for support and stenting of the ostial lad, and distal left main.The 70% stenosis is reduced to 0% with placement of 3.0x9mm bare-metal stent.The non-bsc device was removed after 12 hours due to bleeding around the sheath.In (b)(6) 2016, the patient was diagnosed with left femoral pseudo aneurysm due to which hemostasis could not be achieved.Subsequently, ruptured left femoral pseudo aneurysm was repaired and blood transfusion was done to treat the event.On the same day, the event was considered as resolved.Three days after, the patient was transferred from a chair back to bed, when the patient complained of fatigue.The patient developed profound bradycardia, with slow ventricular complex that progressed to asystole.A code was called and the patient was treated with atropine, epinephrine and external pacing.However, the patient expired due to cardiac arrest with asystole.

• Brand Name: PROMUS ELEMENT¿ PLUS
• 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: 5848463
• MDR Text Key: 51222183
• Report Number: 2134265-2016-06791
• 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: 07/08/2016

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 Expiration Date: 09/09/2013
• Device Model Number: H7493911412250
• Device Catalogue Number: 39114-1225
• Device Lot Number: 15609951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2012
• 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): Death
• Patient Age: 78 YR