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

Model Number H7493952828350

Device Problem Occlusion Within Device (1423)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Edema (1820); Cardiac Enzyme Elevation (1838); Fatigue (1849); Myocardial Infarction (1969); Reocclusion (1985); Heart Failure (2206); Discomfort (2330)

Event Date 10/05/2015

Event Type  Injury  

Manufacturer Narrative

(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 2134265-2015-08553.(b)(4).It was reported that in-stent restenosis and myocardial infarction occurred.On an unknown date, a taxus element stent was implanted in the first obtuse marginal artery (om1).In (b)(6) 2015, the patient had not experienced a myocardial infarction in the 72-hour period prior to the index procedure.The qualifying indications included a positive stress test, crescendo angina, intermediate coronary syndrome, and coronary atherosclerosis of a native vessel.There was 1 target lesion and no non-target lesions.The target lesion was a de novo lesion located in the mid-lad with 80% stenosis.It was 28 mm long, with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation with a 2.75 mm balloon catheter at 10 atmospheres and placement of a 3.50 x 28 mm promus¿ premier stent.Post-dilatation was performed with a 3.5 mm catheter at 18 atmospheres.There was 10% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient was admitted to the hospital with a 2-day history of increasing lower extremity edema and dyspnea and complaints of progressive fatigue and lightheadedness with normal tasks.The patient was diagnosed with acute decompensated heart failure secondary to non st segment myocardial infarction (nstemi).The location of the mi was anteroseptal.The patient was treated with 60 mg lasix intravenous (iv) without response and was admitted to cardiology.80 mg lasix iv twice a day, a heparin drip, and bi-level positive airway pressure (bipap) were also administered.Transient atrial fibrillation in the setting of nstemi resolved after 6 hours; there was no prior record of an ecg with atrial fibrillation.Three days post admission, the 95% isr of the promus premier stent in the mid lad was successfully treated with a 3.5x6mm flextome cutting balloon at 12 atm for 10 seconds, with 0-10% residual stenosis.Thrombolysis in myocardial infarction (timi) flow was 3 both pre and post procedure.On the same day, the 70-80% isr of the taxus element stent in the om1 branch of the left circumflex artery (lcx) was successfully treated with an nc quantum apex balloon at 16 atm for 10 seconds and a 3.5x6mm flextome cutting balloon at 14atm for 10 seconds, with 0-10% residual stenosis.There were no complications.Two days later, the events nstemi and isr were considered resolved and the patient was discharged on aspirin and plavix (clopidogrel).In (b)(6) 2015, the patient experienced chest discomfort at rest, with the discomfort being similar to that which she had experienced prior to previous percutaneous coronary interventions (pci).She also complained of increased lower limb swelling over the prior few days.An ecg revealed new t-wave inversions in leads 2, 3, avf, v5, and v6.The subject was diagnosed with a nstemi.The following day, the 70-80% isr of the promus premier stent in the mid-lad was successfully treated with a 3.5x6mm flextome cutting balloon at 12 atm for 12 seconds and placement of a 3.50x28 mm non-bsc drug eluting stent.The lesion was post dilated with a 3.75x20mm non-bsc balloon at 18atm for 10 seconds, with 0-10% residual stenosis.Thrombolysis in myocardial infarction (timi) flow was 3 both pre and post procedure.The flextome atherectomy caused a very minimal grade a dissection which did not require intervention.Two days after, the events of nstemi and in-stent restenosis (isr) were considered resolved and the subject was discharged on aspirin and plavix (clopidogrel).

• 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: 5279130
• MDR Text Key: 33097594
• Report Number: 2134265-2015-08552
• 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: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: H7493952828350
• Device Catalogue Number: 39528-2835
• Device Lot Number: 17778955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2015
• 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: 65 YR