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

Model Number H7493952812250

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

Patient Problems Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Pleural Effusion (2010); Pulmonary Edema (2020); Pulmonary Insufficiency (2022); Renal Failure (2041); Abdominal Distention (2601)

Event Date 08/04/2015

Event Type  Death  

Manufacturer Narrative

Udi= (b)(4).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: 2134265-2015-08166, 2134265-2015-08164.(b)(6) clinical study.It was reported that death occurred.In (b)(6) 2015, the patient experienced myocardial infarction within 24 hours prior to the index procedure.The current anginal status was recorded as none.Clinical assessment indicated that the patient's qualifying condition was myocardial infarction (mi).The patient was enrolled into the platinum diversity study and underwent an urgent percutaneous coronary intervention (pci) followed by admission to the intensive care unit (icu) for cardiogenic shock and acute respiratory failure.There were three target lesions.Target lesion #1 was a de novo type of lesion located in the proximal left anterior descending artery (lad) with 100% stenosis.It was an ostial lad stent thrombosis.The lesion was 22mm long with a reference vessel diameter of 3.5mm.The thrombolysis in myocardial infarction (timi) flow was 1.This was the culprit lesion for the admission stemi.Target lesion #1 was treated with pre-dilatation with a 2.5mm balloon catheter at 12 atmospheres and insertion of a 3.50 x 24mm promus premier stent.No post dilatation was performed.The residual stenosis was 0%.The post procedural timi flow was 3.Target lesion #2 was a de novo type of lesion located in the mid lad with 100% stenosis.The lesion was 10mm long, with a reference vessel diameter of 2.5 mm.Thrombus was present.Timi flow was 1.This was also considered to be the culprit lesion for the admission stemi.Target lesion #2 was treated with predilatation with a 2.0mm balloon catheter at 12 atmospheres and insertion of a 2.50 x 12mm promus premier stent.No post dilatation was performed.The residual stenosis was 0%.The post procedural timi flow was 3.No thrombus was present.Target lesion #3 was a de novo lesion located in the proximal right coronary artery (rca) with 70% stenosis.The lesion was 22mm long with a reference vessel diameter of 2.75mm.There was moderate calcification.Timi flow was 1.Target lesion #3 was treated with predilatation with a 3.0mm balloon catheter at 16 atmospheres and insertion of a 2.75 x 24 mm promus premier stent.No post dilatation was performed.The residual stenosis was 0%.The post procedural timi flow was 3.The non-target lesion extended from the mid rca to the distal rca.The non-target lesion from the mid-to-distal rca was treated only with angioplasty.Eight days post index procedure, the patient was discharged on aspirin and ticagrelor.In (b)(6) 2015, the patient was seen in the emergency room (er) for increasing shortness of breath at rest with symptoms occurring intermittently over the prior few days.The patient also complained of abdominal distention but denied chest pain.There was no acute distress including respiratory distress.The patient was diagnosed with pulmonary edema, congestive heart failure and acute renal failure.A one-time dose of lasix (furosemide) 40mg via intravenous (iv) therapy was administered.Enzyme testing was ordered in er but results were not reported.The patient was admitted to a step down unit.A pulmonary consultant diagnosed respiratory insufficiency, congestive heart failure and pleural effusion.The patient underwent an image-guided thoracentesis by interventional radiology services.A nephrology consultant diagnosed acute kidney insufficiency versus chronic kidney disease.Per discharge summary, the patient was doing "very poorly day by day".Fourteen days post admission, the patient was found without a pulse and with pupils fixed.The final discharge diagnoses were pulmonary edema, congestive heart failure, acute renal failure, insulin-dependent diabetes mellitus, hypertension, coronary artery disease, prior myocardial infarction, respiratory insufficiency and pleural effusion.An autopsy was not performed.A copy of the death certificate was not available.

• Brand Name: PROMUS PREMIER¿
• 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: 5261355
• MDR Text Key: 32527646
• Report Number: 2134265-2015-08165
• 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: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2016
• Device Model Number: H7493952812250
• Device Catalogue Number: 39528-1225
• Device Lot Number: 17461344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2014
• 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; Required Intervention
• Patient Age: 75 YR